The following data is part of a premarket notification filed by A.p.deauville, Llc. with the FDA for Powerstick Male Latex Condoms.
Device ID | K041717 |
510k Number | K041717 |
Device Name: | POWERSTICK MALE LATEX CONDOMS |
Classification | Condom |
Applicant | A.P.DEAUVILLE, LLC. 594 JERSEY AVE. New Brunswick, NJ 08901 |
Contact | Scott L Baier |
Correspondent | Scott L Baier A.P.DEAUVILLE, LLC. 594 JERSEY AVE. New Brunswick, NJ 08901 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-24 |
Decision Date | 2005-01-13 |
Summary: | summary |