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 |
18859798104945 | K942858 | 000 |