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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K974300
Device Name TELEMED SYSTEMS RETRIEVAL BASKET
Applicant
Telemed Systems, Inc.
19 Brigham St., Unit 1
Marlborough,  MA  01752
Applicant Contact SAMUEL D WADE
Correspondent
Telemed Systems, Inc.
19 Brigham St., Unit 1
Marlborough,  MA  01752
Correspondent Contact SAMUEL D WADE
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received11/17/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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