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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K921873
Device Name QUICKANCHOR, MODIFICATION
Applicant
MITEK SURGICAL PRODUCTS, INC.
57 PROVIDENCE HWY.
NORWOOD,  MA  02062
Applicant Contact ROBERT P ZOLETTI
Correspondent
MITEK SURGICAL PRODUCTS, INC.
57 PROVIDENCE HWY.
NORWOOD,  MA  02062
Correspondent Contact ROBERT P ZOLETTI
Regulation Number888.3030
Classification Product Code
JDR  
Date Received04/08/1992
Decision Date 06/09/1992
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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