The following data is part of a premarket notification filed by Titan Mfg., Inc. with the FDA for Semkin Insulated Bipolar Forcep.
Device ID | K974593 |
510k Number | K974593 |
Device Name: | SEMKIN INSULATED 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 |