TACTYLON CONDOM— 510(k) K971590

Substantially Equivalent

Sensicon Corp.

FDA 510(k) clearance K971590 for TACTYLON CONDOM, Substantially Equivalent on 1997-10-07. Applicant: Sensicon Corp.. Device class: 2.

Clearance details

Applicant: Sensicon Corp.
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1997-05-01
Decision date: 1997-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.