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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K993373
Device Name ROTORBLADE SUTURE ANCHOR
Applicant
Li Medical Technologies, Inc.
4 Armstrong Rd.
Shelton,  CT  06484
Applicant Contact RHODEMANN LI
Correspondent
Li Medical Technologies, Inc.
4 Armstrong Rd.
Shelton,  CT  06484
Correspondent Contact RHODEMANN LI
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
GAS  
Date Received10/07/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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