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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 K915081
Device Name MITEK SNAP PAK(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 01/31/1992
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
Predetermined Change
Control Plan Authorized		 No
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