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510(k) K951519

WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT by Wells Johnson Co. — Product Code FWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1995
Date Received
April 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Cine, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

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  • K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE (December 13, 1994)
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Other clearances for product code FWL

  • K883760 — STORZ MODEL 62 ENT CAMERA SYSTEM (September 28, 1988)