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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Skin Closure
510(k) Number K002315
Device Name WISEBANDS SKIN CLOSURE DEVICE
Applicant
Wisebands , Ltd.
P.O. Box 978
Ra'Anana,  IL 43107
Applicant Contact MARY PAGE
Correspondent
Wisebands , Ltd.
P.O. Box 978
Ra'Anana,  IL 43107
Correspondent Contact MARY PAGE
Regulation Number878.4320
Classification Product Code
MKY  
Date Received07/31/2000
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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