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510(k) K982397

VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM by Angiolaz, Inc. — Product Code FWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1998
Date Received
July 9, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K934682 — SURGICAL VIDEO CAMERA AND ACCESSORIES (February 15, 1994)
  • K932628 — ENDOSCOPIC VIDEO CAMERA (October 15, 1993)