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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K940429
Device Name ORTHO TECH CRYOLOGIC SYSTEM
Applicant
Orthopedic Technology, Inc.
1905 N. Macarthur Dr.
Tracy,  CA  95376
Applicant Contact CALVIN ANDRE
Correspondent
Orthopedic Technology, Inc.
1905 N. Macarthur Dr.
Tracy,  CA  95376
Correspondent Contact CALVIN ANDRE
Regulation Number890.5720
Classification Product Code
ILO  
Date Received01/31/1994
Decision Date 07/12/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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