I-SPOUSE— 510(k) K953089

Substantially Equivalent

Products For Medicine

FDA 510(k) clearance K953089 for I-SPOUSE, Substantially Equivalent on 1995-10-16. Applicant: Products For Medicine. Device class: 1.

Clearance details

Applicant: Products For Medicine
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1995-07-03
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.