The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Disposable Stopcock.
Device ID | K902724 |
510k Number | K902724 |
Device Name: | ADVANCE DISPOSABLE STOPCOCK |
Classification | Stopcock, I.v. Set |
Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
Contact | Ronald Arkin |
Correspondent | Ronald Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-21 |
Decision Date | 1990-12-05 |