Company ยท US
Austenal, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2001. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2001 | K011674 | DC - CRISTAL Austenal, Inc. | EIH |
| Aug 10, 2000 | K001815 | DC ZIRKON Austenal, Inc. | EIH |
| Aug 10, 2000 | K001799 | DC-TELL Austenal, Inc. | EBF |
| Jul 31, 2000 | K001798 | DC TITAN Austenal, Inc. | EJH |
| May 14, 1997 | K970522 | MYERSON'S ECONOMY DENTURE BASE MATERIAL Austenal, Inc. | EBI |
| Apr 21, 1997 | K970205 | VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY Austenal, Inc. | EJH |
| Dec 28, 1995 | K955509 | MIDAS GOLD ELECTROFORMING SYSTEM Austenal, Inc. | EJT |
| Nov 29, 1995 | K954810 | MYERSON IR DENTURE BASE Austenal, Inc. | EBI |
| Jan 5, 1994 | K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL Austenal, Inc. | EBI |
| Nov 4, 1992 | K924526 | DENTURE PLASTIC TEETH Austenal, Inc. | ELM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||