The following data is part of a premarket notification filed by Advanced Diagnostics & Interventions with the FDA for Adi 9000/9001 Arthroscope And Accessories.
Device ID | K992621 |
510k Number | K992621 |
Device Name: | ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES |
Classification | Arthroscope |
Applicant | ADVANCED DIAGNOSTICS & INTERVENTIONS 216 VIA LINDA VISTA Redondo Beach, CA 90277 |
Contact | Antony Fender |
Correspondent | Antony Fender ADVANCED DIAGNOSTICS & INTERVENTIONS 216 VIA LINDA VISTA Redondo Beach, CA 90277 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-05 |
Decision Date | 1999-11-08 |