510(k) K960725
K960725 is an FDA 510(k) premarket notification submitted by Paradigm Medical, Inc. for the device "MARPP PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 15, 1996. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Paradigm Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1996
- Date Received
- February 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Irrigating (Non Dental)
- Device Class
- Class I
- Regulation Number
- 880.6960
- Review Panel
- HO
- Submission Type