The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Latex Condoms W/spermicidal Lubricant (nonoxynol-9).
| Device ID | K942858 |
| 510k Number | K942858 |
| Device Name: | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) |
| Classification | Condom |
| Applicant | SURETEX, LTD. 71 SOI SAP, SIPRAYA, BANGKOK 10500, Thailand, TH 10500 |
| Contact | Ashok Mukherjee |
| Correspondent | Ashok Mukherjee SURETEX, LTD. 71 SOI SAP, SIPRAYA, BANGKOK 10500, Thailand, TH 10500 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-16 |
| Decision Date | 1995-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00070907222102 | K942858 | 000 |
| 00070907216101 | K942858 | 000 |
| 00070907212240 | K942858 | 000 |
| 00070907212127 | K942858 | 000 |
| 00070907208106 | K942858 | 000 |
| 30070907055008 | K942858 | 000 |
| 80070907695520 | K942858 | 000 |