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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 K930918
Device Name HYDROT
Applicant
Sanker Intl., Inc.
P.O. Box 214
Magalia,  CA  95954
Applicant Contact JOHN SANKER
Correspondent
Sanker Intl., Inc.
P.O. Box 214
Magalia,  CA  95954
Correspondent Contact JOHN SANKER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received02/17/1993
Decision Date 05/25/1994
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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