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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 K923161
Device Name BRAIDED POLYESTER SUTURE MATERIAL
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 Received06/29/1992
Decision Date 12/30/1992
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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