510(k) K962288 ยท MMP Cover, Barrier, Protective
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
| Applicant | Pinnacle Products, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 30, 1997 |
| Received | Jun 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962288
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2015 | Penner Mfg Inc Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1
The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nu Terminated |
MMP | None listed |
| Mar 18, 2015 | Sybron Dental Specialties Outer cardboard box labeling:
Pinnacle Cure Sleeve, Curing Light Tip Sleeves.
Kerr Total Care.
Part Number: 4513C or 4513-1
Single Patient Use
Fits 13mm Tips. Pack of 400.
Metrex Research, Manufa Terminated |
MMP | None listed |
| Nov 27, 2012 | Metrex Research, LLC. Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier
The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fl Terminated |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.