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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K864721
Device Name CRYOTHERM
Applicant
Grimm Scientific Industries, Inc.
Box 2143
Marietta,  OH  45750
Applicant Contact JOSEPH E GRIMM
Correspondent
Grimm Scientific Industries, Inc.
Box 2143
Marietta,  OH  45750
Correspondent Contact JOSEPH E GRIMM
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received12/03/1986
Decision Date 02/04/1987
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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