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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K872319
Device Name LN 100 BREAST MARKER
Applicant
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Applicant Contact CLYDE T MARRANGONI
Correspondent
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Correspondent Contact CLYDE T MARRANGONI
Regulation Number878.4800
Classification Product Code
FTY  
Date Received06/17/1987
Decision Date 08/11/1987
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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