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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Water, Temperature Regulated
510(k) Number K812683
Device Name NEONATE FLEXFLOAT
Applicant
Pharmaquest Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pharmaquest Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5560
Classification Product Code
FOH  
Date Received09/22/1981
Decision Date 10/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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