The following data is part of a premarket notification filed by Advantage Diagnostics Corp with the FDA for Cannula, Surgical.
Device ID | K903416 |
510k Number | K903416 |
Device Name: | CANNULA, SURGICAL |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | ADVANTAGE DIAGNOSTICS CORP P.O. BOX 12428 Tucson, AZ 85732 |
Contact | Daniel P Misenhimer |
Correspondent | Daniel P Misenhimer ADVANTAGE DIAGNOSTICS CORP P.O. BOX 12428 Tucson, AZ 85732 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-30 |
Decision Date | 1990-11-23 |