The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Viewmate System.
| Device ID | K071028 |
| 510k Number | K071028 |
| Device Name: | VIEWMATE SYSTEM |
| Classification | Splint, Denis Brown |
| Applicant | EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Contact | Larry Picciano |
| Correspondent | Larry Picciano EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Product Code | ITN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 890.3675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-11 |
| Decision Date | 2007-05-01 |
| Summary: | summary |