Submission Details
| 510(k) Number | K120286 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 2012 |
| Decision Date | June 19, 2012 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
Jun 2012
Decision
140d
Days
Class 2
Risk
About This 510(k) Submission
K120286 is an FDA 510(k) clearance for the TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT, a Condom (Class II — Special Controls, product code HIS), submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on June 19, 2012, 140 days after receiving the submission on January 31, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
Device Classification
| Product Code | HIS — Condom |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
Manufacturer
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