510(k) K872356
K872356 is an FDA 510(k) premarket notification submitted by Mayer Laboratories for the device "CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)". The FDA issued a decision of Substantially Equivalent on April 6, 1988. 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
- April 6, 1988
- Date Received
- June 18, 1987
- 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