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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 K953516
Device Name MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP
Applicant
Yoav Gershoni
19636 Club House Rd.
Suite 125
Gaithersburg,  MD  20879
Applicant Contact YOAV GERSHONI
Correspondent
Yoav Gershoni
19636 Club House Rd.
Suite 125
Gaithersburg,  MD  20879
Correspondent Contact YOAV GERSHONI
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/26/1995
Decision Date 12/08/1995
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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