CONDOMS (MULTIPLE BRANDS)— 510(k) K897129

Substantially Equivalent

Sagami, Inc.

FDA 510(k) clearance K897129 for CONDOMS (MULTIPLE BRANDS), Substantially Equivalent on 1990-05-16. Applicant: Sagami, Inc.. Device class: 2.

Clearance details

Applicant: Sagami, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1989-12-26
Decision date: 1990-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.