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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K810543
Device Name NEO-WAVE SYSTEM
Applicant
Gaymar Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gaymar Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5160
Classification Product Code
INX  
Date Received02/27/1981
Decision Date 03/06/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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