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 Glycerine Lubricant.
| Device ID | K010371 |
| 510k Number | K010371 |
| Device Name: | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT |
| Classification | Condom |
| Applicant | SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 Dothan, AL 36302 |
| Contact | Lon D Mcilvain |
| Correspondent | Lon D Mcilvain 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 | 2001-02-07 |
| Decision Date | 2001-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30070907298559 | K010371 | 000 |
| 80070907692574 | K010371 | 000 |
| 18859798101043 | K010371 | 000 |