510(k) K941258
K941258 is an FDA 510(k) premarket notification submitted by Suretex, Ltd. for the device "LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on Dec 6, 1995. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suretex, Ltd. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 6, 1995
- Date Received
- Mar 16, 1994
- 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
- 510(k)