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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 K953352
Device Name PROTEAM CUSHION
Applicant
Iskra.Med
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact MILTON N BENEKE
Correspondent
Iskra.Med
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact MILTON N BENEKE
Regulation Number890.3175
Classification Product Code
KIC  
Date Received07/17/1995
Decision Date 11/29/1995
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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