510(k) K011253
K011253 is an FDA 510(k) premarket notification submitted by Thai Nippon Rubber Industry Co., Ltd. for the device "FLAVORED MALE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on July 20, 2001. 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
- July 20, 2001
- Date Received
- April 24, 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