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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 K030031
Device Name SOFT TISSUE ANCHORING WASHERS
Applicant
Accu-Speed, Incorporated
P.O. Box 1008, 65 Gay Rd.
Groton,  MA  01450
Applicant Contact ROBERT W SECOVICH
Correspondent
Accu-Speed, Incorporated
P.O. Box 1008, 65 Gay Rd.
Groton,  MA  01450
Correspondent Contact ROBERT W SECOVICH
Regulation Number878.4930
Classification Product Code
KGS  
Subsequent Product Code
MBI  
Date Received01/03/2003
Decision Date 01/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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