The following data is part of a premarket notification filed by American Medical Concepts, Inc. with the FDA for Sight-plus Arthroscope.
Device ID | K925226 |
510k Number | K925226 |
Device Name: | SIGHT-PLUS ARTHROSCOPE |
Classification | Arthroscope |
Applicant | AMERICAN MEDICAL CONCEPTS, INC. 1544 SAWDUST RD., SUITE 502 The Woodlands, TX 77380 |
Contact | Richard L Benson |
Correspondent | Richard L Benson AMERICAN MEDICAL CONCEPTS, INC. 1544 SAWDUST RD., SUITE 502 The Woodlands, TX 77380 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-16 |
Decision Date | 1993-07-28 |