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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 K945067
Device Name EBICE
Applicant
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Applicant Contact SHARON A STAROWICZ
Correspondent
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Correspondent Contact SHARON A STAROWICZ
Regulation Number890.5720
Classification Product Code
ILO  
Date Received10/14/1994
Decision Date 02/09/1995
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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