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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K930675
Device Name MITEK CONE WASHER
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 Number878.4930
Classification Product Code
KGS  
Date Received02/09/1993
Decision Date 11/09/1993
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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