510(k) K896984
K896984 is an FDA 510(k) premarket notification submitted by Dura Pharmaceuticals, Inc. for the device "PARI I.S.-2". The FDA issued a decision of SN on March 9, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Dura Pharmaceuticals, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 9, 1990
- Date Received
- December 11, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type