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510(k) K913587

JTECH 50 SERIES CUTTING LOOP by J-Tech, Inc. — Product Code FJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
August 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by J-Tech, Inc.

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  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K912526 — GS-220 HAND IMPAIRMENT EVALUATION SYSTEM (September 5, 1991)

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