REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT— 510(k) K993396
Substantially EquivalentRemed Pharma
FDA 510(k) clearance K993396 for REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT, Substantially Equivalent on 2000-02-15. Applicant: Remed Pharma. Device class: 2.
Clearance details
- Applicant
- Remed Pharma
- Product code
- Code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Crofton, MD, US
Recent devices under product code HIS
view allMore clearances from Remed Pharma
view all- K993389 — REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
- K993403 — REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
- K993409 — REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
- K993395 — REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
- K993404 — REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.