PREVENTOR AND PROTECTOR LATEX CONDOMS— 510(k) K945246
Substantially EquivalentAmerican Pharmaceutical Co., Inc.
FDA 510(k) clearance K945246 for PREVENTOR AND PROTECTOR LATEX CONDOMS, Substantially Equivalent on 1995-09-07. Applicant: American Pharmaceutical Co., Inc.. Device class: 2.
Clearance details
- Applicant
- American Pharmaceutical Co., Inc.
- 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
- Traditional
- Location
- Parsippany, NJ, US
Recent devices under product code HIS
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