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 |
18859798104907 | K030176 | 000 |