The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Rovenstein Forceps.
| Device ID | K880318 |
| 510k Number | K880318 |
| Device Name: | ROVENSTEIN FORCEPS |
| Classification | Forceps, Tube Introduction |
| Applicant | EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Contact | Supti Putatunda |
| Correspondent | Supti Putatunda EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Product Code | BWB |
| CFR Regulation Number | 868.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-03-21 |