ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS— 510(k) K981621

Name: FDA 510(k) clearance K981621
Creator: U.S. Food and Drug Administration
Published: 1998-06-19

Substantially Equivalent

Suretex Prophylactics (India) , Ltd.

FDA 510(k) clearance K981621 for ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS, Substantially Equivalent on 1998-06-19. Applicant: Suretex Prophylactics (India) , Ltd.. Device class: 2.

Clearance details

Applicant: Suretex Prophylactics (India) , Ltd.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1998-05-06
Decision date: 1998-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, Karnataka, IN

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