The following data is part of a premarket notification filed by Tnco, Inc. with the FDA for Monopolar Endoscopic Reposable Tip Surgical Instruments.
| Device ID | K943958 |
| 510k Number | K943958 |
| Device Name: | MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TNCO, INC. 15 COLEBROOK BLVD. P.O. BOX 231 Whitman, MA 02382 |
| Contact | Karin Dolan |
| Correspondent | Karin Dolan TNCO, INC. 15 COLEBROOK BLVD. P.O. BOX 231 Whitman, MA 02382 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1994-09-07 |