HEATPAC— 510(k) K810320

Substantially Equivalent

Shinsei Corp.

FDA 510(k) clearance K810320 for HEATPAC, Substantially Equivalent on 1981-03-04. Applicant: Shinsei Corp.. Device class: 2.

Clearance details

Applicant: Shinsei Corp.
Product code: Code IMB
Device class: Class 2
Regulation: 21 CFR 890.5250
Advisory panel: Physical Medicine
Date received: 1981-02-06
Decision date: 1981-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.