CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH— 510(k) K970767

Name: FDA 510(k) clearance K970767
Creator: U.S. Food and Drug Administration
Published: 1997-06-02

Substantially Equivalent

Custom Services Intl., Inc.

FDA 510(k) clearance K970767 for CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH, Substantially Equivalent on 1997-06-02. Applicant: Custom Services Intl., Inc.. Device class: 2.

Clearance details

Applicant: Custom Services Intl., Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-03
Decision date: 1997-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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