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 |