The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for Thai Nippon Male Latex Condom.
Device ID | K081265 |
510k Number | K081265 |
Device Name: | THAI NIPPON MALE LATEX CONDOM |
Classification | Condom |
Applicant | THAI NIPPON RUBBER INDUSTRY CO., LTD. PO BOX 12139 Durham, NC 27709 |
Contact | Eli J Carter |
Correspondent | Eli J Carter THAI NIPPON RUBBER INDUSTRY CO., LTD. PO BOX 12139 Durham, NC 27709 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-05 |
Decision Date | 2009-10-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850281004477 | K081265 | 000 |
00850281004460 | K081265 | 000 |
00850281004453 | K081265 | 000 |