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510(k) K971918 · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

AMERIGEL OINTMENT SATURATED WOUND DRESSING

Applicant	Amerx Health Care Corp., Clearwater FL, US
Decision	Substantially Equivalent, Aug 12, 1997
Received	May 23, 1997
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K971918

Date	Firm and product	Code	Linked 510(k)
Jun 12, 2015	Amerx Health Care Corp. Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. Terminated	MGQ	None listed
Dec 4, 2014	Amerx Health Care Corp. Amerigel Hydrogel Wound Dressing Wound management Terminated	MGQ	None listed
Dec 4, 2014	Amerx Health Care Corp. Amerigel Post-op Surgical Kits Wound management Terminated	MGQ	None listed
Dec 4, 2014	Amerx Health Care Corp. Amerigel Daily Dressing Packets Wound management Terminated	MGQ	None listed
Dec 4, 2014	Amerx Health Care Corp. Amerigel Saturated Gauze Dressing Wound management Terminated	MGQ	None listed
Sep 12, 2014	Amerx Health Care Corp. Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. Terminated	MGQ	None listed
Sep 12, 2014	Amerx Health Care Corp. Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management. Terminated	MGQ	None listed
Sep 12, 2014	Amerx Health Care Corp. Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management. Terminated	MGQ	None listed
Sep 12, 2014	Amerx Health Care Corp. Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management. Terminated	MGQ	None listed
Jul 4, 2014	Kova Laboratories, Inc. Amerigel Wound Dressing 1 oz. tube Terminated	MGQ	None listed
Jul 4, 2014	Kova Laboratories, Inc. Amerigel Wound Dressing 55 gallons/drum Terminated	MGQ	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.