510(k) K865106
K865106 is an FDA 510(k) premarket notification submitted by Medelec Intl. Corp. for the device "PROPHYLACTIC (CONDOM) MR. JOHNNY". The FDA issued a decision of Substantially Equivalent on May 20, 1987. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Medelec Intl. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1987
- Date Received
- December 31, 1986
- 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