The following data is part of a premarket notification filed by Titan Mfg., Inc. with the FDA for Semkin Bipolar Forcep.
| Device ID | K974594 |
| 510k Number | K974594 |
| Device Name: | SEMKIN BIPOLAR FORCEP |
| Classification | Forceps |
| Applicant | TITAN MFG., INC. 6 JAMIE LN. Phoenixville, PA 19460 |
| Contact | Donald Seavey |
| Correspondent | Donald Seavey TITAN MFG., INC. 6 JAMIE LN. Phoenixville, PA 19460 |
| Product Code | HTD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-09 |
| Decision Date | 1998-06-24 |