The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Lifestyles, Contempo Or Private Label-male Latex Condom With Desensitizing Lubricant.
| Device ID | K030176 |
| 510k Number | K030176 |
| Device Name: | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT |
| Classification | Condom |
| Applicant | SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan, AL 36302 |
| Contact | Cynthia A Ingram |
| Correspondent | Cynthia A Ingram SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan, AL 36302 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-17 |
| Decision Date | 2003-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00070907209103 | K030176 | 000 |
| 18859798101319 | K030176 | 000 |
| 18859798101180 | K030176 | 000 |