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510(k) K840144

YAG LASER 8000 GASTROINTESTINAL BLEE by Cooper Medical Corp. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1984
Date Received
January 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Cooper Medical Corp.

  • K833387 — ARGON LASER SURGICAL SYSTEM 770 (April 18, 1984)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)
  • K832703 — ARGON LASER SYS-MODEL 5000 (January 30, 1984)
  • K820261 — MONITOR CO2 LASER SYSTEM (March 5, 1982)

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