The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Cottle Lower Lateral Forceps.
Device ID | K772398 |
510k Number | K772398 |
Device Name: | COTTLE LOWER LATERAL FORCEPS |
Classification | Forceps, Ent |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KAE |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-27 |
Decision Date | 1978-01-17 |