510(k) K880185
K880185 is an FDA 510(k) premarket notification submitted by American Laboratories, Inc. for the device "DUET (CONDOMS)". The FDA issued a decision of Substantially Equivalent on June 17, 1988. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1988
- Date Received
- January 15, 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