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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
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