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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 K940554
Device Name TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS
Applicant
Tnco, Inc.
15 Colebrook Blvd.
P.O. Box 231
Whitman,  MA  02382
Applicant Contact KARIN DOLAN
Correspondent
Tnco, Inc.
15 Colebrook Blvd.
P.O. Box 231
Whitman,  MA  02382
Correspondent Contact KARIN DOLAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/07/1994
Decision Date 06/29/1994
Decision Substantially Equivalent - Kit (SESK)
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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