SAFECON CONDOMS - PINK COLOR— 510(k) K896623
Substantially EquivalentQuality Synthetics Intl, Inc.
FDA 510(k) clearance K896623 for SAFECON CONDOMS - PINK COLOR, Substantially Equivalent on 1990-02-16. Applicant: Quality Synthetics Intl, Inc.. Device class: 2.
Clearance details
- Applicant
- Quality Synthetics Intl, 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
- Garden Grove, CA, US
Recent devices under product code HIS
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