TUSTEX FLAVORED CONDOMS— 510(k) K970633

Substantially Equivalent

Line One Laboratories

FDA 510(k) clearance K970633 for TUSTEX FLAVORED CONDOMS, Substantially Equivalent on 1997-03-21. Applicant: Line One Laboratories. Device class: 2.

Clearance details

Applicant: Line One Laboratories
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1997-02-20
Decision date: 1997-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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