The following data is part of a premarket notification filed by Paradigm Medical, Inc. with the FDA for Marpp Pressure Monitoring System.
| Device ID | K960725 |
| 510k Number | K960725 |
| Device Name: | MARPP PRESSURE MONITORING SYSTEM |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | PARADIGM MEDICAL, INC. 1955 RAYMOND DR. SUITE 103 Northbrook, IL 60062 |
| Contact | Larry Kluge |
| Correspondent | Larry Kluge PARADIGM MEDICAL, INC. 1955 RAYMOND DR. SUITE 103 Northbrook, IL 60062 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-22 |
| Decision Date | 1996-07-15 |