510(k) K904508

CONDOR ANALOG INFLATION SYRINGE by Professional Medical Services — Product Code MAV

K904508 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "CONDOR ANALOG INFLATION SYRINGE". The FDA issued a decision of Substantially Equivalent on April 2, 1991. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1991
Date Received
October 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type