The following data is part of a premarket notification filed by Gynopharma, Inc. with the FDA for Probet (tm).
| Device ID | K903002 |
| 510k Number | K903002 |
| Device Name: | PROBET (TM) |
| Classification | Aspirator, Endometrial |
| Applicant | GYNOPHARMA, INC. C/O ELLIS PHARM CONSULTING INC 913 STATE ROAD Princeton, NJ 08540 |
| Contact | Levi Ellis |
| Correspondent | Levi Ellis GYNOPHARMA, INC. C/O ELLIS PHARM CONSULTING INC 913 STATE ROAD Princeton, NJ 08540 |
| Product Code | HFF |
| CFR Regulation Number | 884.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-09 |
| Decision Date | 1991-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425017500377 | K903002 | 000 |
| 25425017500036 | K903002 | 000 |