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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drape, surgical
510(k) Number K920340
Device Name SUTURE REMOVAL KIT
Applicant
MEDIKMARK, INC.
333 WEST WACKER DR.
SUITE 2600
chicago,  IL  60606
Applicant Contact richard o wood
Correspondent
MEDIKMARK, INC.
333 WEST WACKER DR.
SUITE 2600
chicago,  IL  60606
Correspondent Contact richard o wood
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/24/1992
Decision Date 04/23/1992
Decision substantially equivalent - kit with drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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