The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Bonn Micro Iris Hook (non-sterile) #7613.
| Device ID | K801469 |
| 510k Number | K801469 |
| Device Name: | BONN MICRO IRIS HOOK (NON-STERILE) #7613 |
| 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 | 1980-06-24 |
| Decision Date | 1980-07-28 |