510(k) K970792
K970792 is an FDA 510(k) premarket notification submitted by Titan Condoms for the device "INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE". The FDA issued a decision of Substantially Equivalent on June 2, 1997. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Titan Condoms has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1997
- Date Received
- March 4, 1997
- 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