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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K800812
Device Name MEDI-THERM
Applicant
Gaymar Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gaymar Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/11/1980
Decision Date 04/24/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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