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 |