The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Male Natural Rubber Latex Condom.
Device ID | K010919 |
510k Number | K010919 |
Device Name: | MALE NATURAL RUBBER 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 | 2001-03-27 |
Decision Date | 2001-06-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850836007328 | K010919 | 000 |