The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Carroll Tendon Retriever.
Device ID | K772393 |
510k Number | K772393 |
Device Name: | CARROLL TENDON RETRIEVER |
Classification | Forceps, General & Plastic Surgery |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-27 |
Decision Date | 1978-05-09 |