510(k) K013773
K013773 is an FDA 510(k) premarket notification submitted by Ssn Medical Products Sdn. Bhd. for the device "SAFE". The FDA issued a decision of Substantially Equivalent on Jan 24, 2002. 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
- Jan 24, 2002
- Date Received
- Nov 13, 2001
- Clearance Type
- Abbreviated
- 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
- 510(k)