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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyester
510(k) Number K915089
Device Name MITEK QUICKANCHOR(TM), 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 Number878.5000
Classification Product Code
GAS  
Date Received11/12/1991
Decision Date 02/03/1992
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
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