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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K844580
Device Name MEDCOLATOR MODEL HVX
Applicant
Medco Products, Co., Inc.
31 Park Rd.
P.O. Box E
Tinton Falls,  NJ  07724
Applicant Contact RICHARD N LORD
Correspondent
Medco Products, Co., Inc.
31 Park Rd.
P.O. Box E
Tinton Falls,  NJ  07724
Correspondent Contact RICHARD N LORD
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/23/1984
Decision Date 02/25/1985
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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