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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Needle; Orthopedic
510(k) Number K872989
Device Name MICRINS NEEDLE HOLDER
Applicant
Micrins Surgical, Inc.
325 W. Huron, Suite 411
Chicago,  IL  60610
Applicant Contact BERNHARD TEITZ
Correspondent
Micrins Surgical, Inc.
325 W. Huron, Suite 411
Chicago,  IL  60610
Correspondent Contact BERNHARD TEITZ
Regulation Number888.4540
Classification Product Code
HXK  
Date Received07/31/1987
Decision Date 08/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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