The following data is part of a premarket notification filed by Eagle Twe, Inc. with the FDA for Divas Dual Pleasure Male Latex Condom.
| Device ID | K051273 |
| 510k Number | K051273 |
| Device Name: | DIVAS DUAL PLEASURE MALE LATEX CONDOM |
| Classification | Condom |
| Applicant | EAGLE TWE, INC. 2090 TUCKER INDUSTRIAL ROAD SUITE A-5 Tucker, GA 30084 |
| Contact | Bill Taffs |
| Correspondent | Bill Taffs EAGLE TWE, INC. 2090 TUCKER INDUSTRIAL ROAD SUITE A-5 Tucker, GA 30084 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-17 |
| Decision Date | 2005-08-19 |
| Summary: | summary |