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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K875319
Device Name NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS
Applicant
I-Tech Industries, Inc.
849 Westwood Ave.
Addison,  IL  60101
Applicant Contact M GENDRIKOVS
Correspondent
I-Tech Industries, Inc.
849 Westwood Ave.
Addison,  IL  60101
Correspondent Contact M GENDRIKOVS
Regulation Number878.4800
Classification Product Code
GEN  
Date Received12/29/1987
Decision Date 01/22/1988
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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