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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Flotation
510(k) Number K950085
Device Name MULTICURE(R) S GEL PAD
Applicant
Multigestion (Deutschland) GmbH
Lebuis/Latour Du Pin
Saint Victor De Gessieu,  FR
Applicant Contact FRANCOIS-XAVIER WEISS
Correspondent
Multigestion (Deutschland) GmbH
Lebuis/Latour Du Pin
Saint Victor De Gessieu,  FR
Correspondent Contact FRANCOIS-XAVIER WEISS
Regulation Number890.3175
Classification Product Code
KIC  
Date Received01/10/1995
Decision Date 07/13/1995
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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