REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT— 510(k) K993408
Substantially EquivalentRemed Pharma
FDA 510(k) clearance K993408 for REMED MALE RIBBED 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
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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
- K993396 — REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.