510(k) K895836
K895836 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INFLATION PRO II". The FDA issued a decision of Substantially Equivalent on Dec 20, 1989. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 1989
- Date Received
- Oct 3, 1989
- 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
- 510(k)