510(k) K904508
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