HEATPAC

Cabinet, Moist Steam

SHINSEI CORP.

The following data is part of a premarket notification filed by Shinsei Corp. with the FDA for Heatpac.

Pre-market Notification Details

Device IDK810320
510k NumberK810320
Device Name:HEATPAC
ClassificationCabinet, Moist Steam
Applicant SHINSEI CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIMB  
CFR Regulation Number890.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-06
Decision Date1981-03-04

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