The following data is part of a premarket notification filed by Innolatex (thailand) Limited with the FDA for Male Latex Condom (straight Side Or Contoured Or Flared In Shape, Either Textured Or Non-textured , Lubricated Or Non-lu.
| Device ID | K092586 |
| 510k Number | K092586 |
| Device Name: | MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU |
| Classification | Condom |
| Applicant | INNOLATEX (THAILAND) LIMITED SOUTHERN INDUSTRIAL ESTATE VILLAGE 4 CHALUNG SUB-DISTRICT Hatyai District, Songkhla, TH 90110 |
| Contact | Goh Saing |
| Correspondent | Goh Saing INNOLATEX (THAILAND) LIMITED SOUTHERN INDUSTRIAL ESTATE VILLAGE 4 CHALUNG SUB-DISTRICT Hatyai District, Songkhla, TH 90110 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2010-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000026 | K092586 | 000 |
| 80726893800249 | K092586 | 000 |
| 80726893800126 | K092586 | 000 |
| 80022600642035 | K092586 | 000 |
| 80022600926203 | K092586 | 000 |
| 00726893112612 | K092586 | 000 |
| 00726893113466 | K092586 | 000 |
| 80022600937520 | K092586 | 000 |
| 80022600019448 | K092586 | 000 |
| 00726893112551 | K092586 | 000 |
| 00726893112605 | K092586 | 000 |
| 00726893112575 | K092586 | 000 |
| 00726893112582 | K092586 | 000 |
| 00726893112599 | K092586 | 000 |
| 00726893112537 | K092586 | 000 |
| 00726893112544 | K092586 | 000 |
| 00813356000002 | K092586 | 000 |
| 00813356000019 | K092586 | 000 |
| 80726893800256 | K092586 | 000 |