The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Disposable Slide Valve Manifold.
Device ID | K913094 |
510k Number | K913094 |
Device Name: | DISPOSABLE SLIDE VALVE MANIFOLD |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Contact | James E Williams |
Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-12 |
Decision Date | 1992-01-27 |