The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Mcculley Continuous Suture Tightner.
| Device ID | K801608 |
| 510k Number | K801608 |
| Device Name: | MCCULLEY CONTINUOUS SUTURE TIGHTNER |
| Classification | Spatula, Ophthalmic |
| Applicant | EDWARD WECK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HND |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-15 |
| Decision Date | 1980-08-12 |