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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K852943
Device Name NEO SHIELD
Applicant
Gaymar Industries, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Applicant Contact JOHN PHILLIPS
Correspondent
Gaymar Industries, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Correspondent Contact JOHN PHILLIPS
Regulation Number880.5130
Classification Product Code
FMT  
Date Received07/11/1985
Decision Date 11/08/1985
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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