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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K915119
Device Name SCALPEL BLADE REMOVER (BLADEGARD)
Applicant
Intergrated Visual, Inc.
Boatmen"S Bank Buiding
6th & Hampshire Suite 609
Quincy,  IL  62301
Applicant Contact RICHARD K.HESS
Correspondent
Intergrated Visual, Inc.
Boatmen"S Bank Buiding
6th & Hampshire Suite 609
Quincy,  IL  62301
Correspondent Contact RICHARD K.HESS
Regulation Number878.4800
Classification Product Code
GES  
Date Received11/13/1991
Decision Date 05/05/1992
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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