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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K926126
Device Name SUTUREMATE
Applicant
Surgical Safety Products, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
Surgical Safety Products, Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number878.4800
Classification Product Code
MDM  
Date Received12/04/1992
Decision Date 05/19/1993
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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