510(k) K955648
K955648 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "K-Y PERSONAL LUBRICANT". The FDA issued a decision of Substantially Equivalent on June 21, 1996. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1996
- Date Received
- December 12, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type