The following data is part of a premarket notification filed by Pharmaceutical Innovations, Inc. with the FDA for Evron Gel.
| Device ID | K961222 |
| 510k Number | K961222 |
| Device Name: | EVRON GEL |
| Classification | Lubricant, Patient |
| Applicant | PHARMACEUTICAL INNOVATIONS, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Larry R Pilot |
| Correspondent | Larry R Pilot PHARMACEUTICAL INNOVATIONS, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-28 |
| Decision Date | 1996-06-26 |
| Summary: | summary |