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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K943958
Device Name MONOPOLAR ENDOSCOPIC REPOSABLE TIP 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 Number876.1500
Classification Product Code
GCJ  
Date Received08/15/1994
Decision Date 09/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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