The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Clamps And Clips.
Device ID | K942896 |
510k Number | K942896 |
Device Name: | CLAMPS AND CLIPS |
Classification | Instrument, Manual, Surgical, General Use |
Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
Contact | Don W Haar |
Correspondent | Don W Haar SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
Product Code | MDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-20 |
Decision Date | 1994-07-19 |