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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Elastic
510(k) Number K952738
Device Name SKIN SAVER SYSTEMS
Applicant
Skin Saver Systems, Inc.
18158 E. Long Ave.
Aurora,  CO  80016
Applicant Contact BARRY F SHESOL
Correspondent
Skin Saver Systems, Inc.
18158 E. Long Ave.
Aurora,  CO  80016
Correspondent Contact BARRY F SHESOL
Regulation Number880.5075
Classification Product Code
FQM  
Date Received06/14/1995
Decision Date 09/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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