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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 K860632
Device Name EBI HAND MASSAGING PUMP (HMP)
Applicant
Electro-Biology, Inc.
300 Fairfield Rd.
Fairfield,  NJ  07006
Applicant Contact ANTHONY C PARKES
Correspondent
Electro-Biology, Inc.
300 Fairfield Rd.
Fairfield,  NJ  07006
Correspondent Contact ANTHONY C PARKES
Regulation Number890.5650
Classification Product Code
IRP  
Date Received02/20/1986
Decision Date 04/18/1986
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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