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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K011202
Device Name MSI BIPOLAR SHEATH
Applicant
Medical Scientific, Inc.
125 John Hancock Rd.
Taunton,  MA  02780
Applicant Contact PAUL NARDELLA
Correspondent
Medical Scientific, Inc.
125 John Hancock Rd.
Taunton,  MA  02780
Correspondent Contact PAUL NARDELLA
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received04/19/2001
Decision Date 12/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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