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FDA 510(k) Application Details - K992402
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K992402
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
TELEMED SYSTEMS, INC.
19 BRIGHAM ST., UNIT 1
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact
JOHN A CHAVES
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/1999
Decision Date
12/22/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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