The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Hooks #'s 7600,7602,7603,7616.
Device ID | K791985 |
510k Number | K791985 |
Device Name: | HOOKS #'S 7600,7602,7603,7616 |
Classification | Hook, Ophthalmic |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNQ |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-25 |
Decision Date | 1979-10-04 |