The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Tongue Seizing Forceps With & Without Rubber Pads.
| Device ID | K884584 |
| 510k Number | K884584 |
| Device Name: | TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS |
| Classification | Forceps, Tube Introduction |
| Applicant | EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Contact | Rathin Putatunda |
| Correspondent | Rathin 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 | 1988-11-02 |
| Decision Date | 1988-11-14 |