510(k) K081265
K081265 is an FDA 510(k) premarket notification submitted by Thai Nippon Rubber Industry Co., Ltd. for the device "THAI NIPPON MALE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on October 16, 2009. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Thai Nippon Rubber Industry Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2009
- Date Received
- May 5, 2008
- 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