510(k) K992081
K992081 is an FDA 510(k) premarket notification submitted by Suretex Prophylactics (India) , Ltd. for the device "VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL". The FDA issued a decision of Substantially Equivalent on August 19, 1999. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suretex Prophylactics (India) , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1999
- Date Received
- June 21, 1999
- 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