The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Gynesurg.
| Device ID | K780587 |
| 510k Number | K780587 |
| Device Name: | GYNESURG |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | POLAMEDCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-11 |
| Decision Date | 1978-05-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GYNESURG 73174890 1124448 Dead/Cancelled |
POLAMEDCO, INC. 1978-06-19 |