510(k) K961222
K961222 is an FDA 510(k) premarket notification submitted by Pharmaceutical Innovations, Inc. for the device "EVRON GEL". The FDA issued a decision of Substantially Equivalent on June 26, 1996. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Pharmaceutical Innovations, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1996
- Date Received
- March 28, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Patient
- Device Class
- Class I
- Regulation Number
- 880.6375
- Review Panel
- HO
- Submission Type