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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K951769
Device Name CRYOPRESS
Applicant
Grimm Scientific Industries, Inc.
Newport Pike
Marietta,  OH  45750
Applicant Contact JOSEPH E GRIMM
Correspondent
Grimm Scientific Industries, Inc.
Newport Pike
Marietta,  OH  45750
Correspondent Contact JOSEPH E GRIMM
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received04/17/1995
Decision Date 10/16/1995
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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