The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for 56mm Condom,male Natural Rubber Latex Condom.
| Device ID | K012964 |
| 510k Number | K012964 |
| Device Name: | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM |
| Classification | Condom |
| Applicant | INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e., MY 40150 |
| Contact | Chang Ah-kau |
| Correspondent | Chang Ah-kau INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e., MY 40150 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850836007502 | K012964 | 000 |
| 00850002174687 | K012964 | 000 |