The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Cardiovascular Instruments-various.
| Device ID | K791710 |
| 510k Number | K791710 |
| Device Name: | CARDIOVASCULAR INSTRUMENTS-VARIOUS |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-27 |
| Decision Date | 1979-09-12 |