510(k) K946376
K946376 is an FDA 510(k) premarket notification submitted by Mayer Laboratories for the device "MAXX". The FDA issued a decision of Substantially Equivalent on September 22, 1995. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Mayer Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1995
- Date Received
- December 14, 1994
- 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