The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Suture Set Or Laceration Trays (packs).
Device ID | K932219 |
510k Number | K932219 |
Device Name: | SUTURE SET OR LACERATION TRAYS (PACKS) |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
Contact | Scott Weiss |
Correspondent | Scott Weiss ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-07 |
Decision Date | 1993-07-09 |