The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Non-spermicidal Lubricated Male Latex Condom.
Device ID | K002393 |
510k Number | K002393 |
Device Name: | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
Classification | Condom |
Applicant | INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, Shah Alam,selangor Darul Ehsan, MY |
Contact | Chang Ah-kau |
Correspondent | Chang Ah-kau INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, Shah Alam,selangor Darul Ehsan, MY |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-07 |
Decision Date | 2000-12-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00812420030037 | K002393 | 000 |
00850836007410 | K002393 | 000 |
00850836007342 | K002393 | 000 |
00850836007250 | K002393 | 000 |
00850836007212 | K002393 | 000 |
00850002174205 | K002393 | 000 |
00850002174199 | K002393 | 000 |
20812420030031 | K002393 | 000 |