510(k) K971590
K971590 is an FDA 510(k) premarket notification submitted by Sensicon Corp. for the device "TACTYLON CONDOM". The FDA issued a decision of Substantially Equivalent on October 7, 1997. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Sensicon Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1997
- Date Received
- May 1, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom, Synthetic
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type