ALATECH LATEX CONDOM— 510(k) K993887

Substantially Equivalent

Alatech Healthcare, LLC

FDA 510(k) clearance K993887 for ALATECH LATEX CONDOM, Substantially Equivalent on 1999-12-20. Applicant: Alatech Healthcare, LLC. Device class: 2.

Clearance details

Applicant: Alatech Healthcare, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1999-11-16
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Slocomb, AL, 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.