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510(k) K950712

PORTABLE ENDOSCOPY SYSTEM by Laser-Optik-Systeme GmbH & Co. KG — Product Code GCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1996
Date Received
February 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Laser-Optik-Systeme GmbH & Co. KG

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  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)

Other clearances for product code GCM

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  • K001217 — INSIDE VIEW (July 11, 2000)
  • K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOS (December 10, 1999)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (September 17, 1996)
  • K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR (January 26, 1996)
  • K935235 — ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY (March 23, 1995)
  • K945889 — KARL STORZ PLASTIC SURGERY ACCESSORIES (March 22, 1995)
  • K931954 — THORACOSCOPE/LAPAROSCOPE (November 2, 1993)