The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Beaver Cataract Cyroxtractor.
| Device ID | K781338 |
| 510k Number | K781338 |
| Device Name: | BEAVER CATARACT CYROXTRACTOR |
| Classification | Unit, Cryophthalmic |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-04 |
| Decision Date | 1979-02-12 |