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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K943392
Device Name THERA-FLOW GRADIENT SEQUENTIAL PUMP
Applicant
Meds Systems, Inc.
1110 Business Pkwy. S.
Westminster,  MD  21157
Applicant Contact CHARLES GREMPLER
Correspondent
Meds Systems, Inc.
1110 Business Pkwy. S.
Westminster,  MD  21157
Correspondent Contact CHARLES GREMPLER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/14/1994
Decision Date 12/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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