The following data is part of a premarket notification filed by Tnco, Inc. with the FDA for Tnco, Inc. Arthroscopic Surgical Instruments.
Device ID | K940554 |
510k Number | K940554 |
Device Name: | TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-07 |
Decision Date | 1994-06-29 |