EXTRAWEAR, GENTLEMEN'S CHOICE— 510(k) K972428

Name: FDA 510(k) clearance K972428
Creator: U.S. Food and Drug Administration
Published: 1997-08-25

Substantially Equivalent

Custom Services Intl., Inc.

FDA 510(k) clearance K972428 for EXTRAWEAR, GENTLEMEN'S CHOICE, Substantially Equivalent on 1997-08-25. 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: 1997-06-27
Decision date: 1997-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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