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510(k) K042615

CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE by Carbon Medical Technologies, Inc. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2004
Date Received
September 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

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