The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Dexon S, Dexon Plus, And Dexon Ii Polycolic Acid.
Device ID | K930588 |
510k Number | K930588 |
Device Name: | DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Contact | John Schaefer |
Correspondent | John Schaefer DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-04 |
Decision Date | 1994-01-07 |