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 |