510(k) K884468
K884468 is an FDA 510(k) premarket notification submitted by Mayer Laboratories for the device "SUPER MAXX OTHERS (MULTIPLE) CONDOMS". The FDA issued a decision of Substantially Equivalent on March 31, 1989. 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
- March 31, 1989
- Date Received
- October 25, 1988
- 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