The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Condor Digital Inflation Syringe.
Device ID | K904954 |
510k Number | K904954 |
Device Name: | CONDOR DIGITAL INFLATION SYRINGE |
Classification | Syringe, Balloon Inflation |
Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Contact | James Williams |
Correspondent | James Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Product Code | MAV |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-05 |
Decision Date | 1991-01-16 |