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510(k) K833497

COOPER MEDICAL MODEL 770 by Cooper Medical Corp. — Product Code LLF

K833497 is an FDA 510(k) premarket notification submitted by Cooper Medical Corp. for the device "COOPER MEDICAL MODEL 770". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code LLF (Laser, Neurosurgical, Argon), a Class III device. Cooper Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
October 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neurosurgical, Argon
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Cooper Medical Corp.

  • K840144 — YAG LASER 8000 GASTROINTESTINAL BLEE (May 18, 1984)
  • K833387 — ARGON LASER SURGICAL SYSTEM 770 (April 18, 1984)
  • K832703 — ARGON LASER SYS-MODEL 5000 (January 30, 1984)
  • K820261 — MONITOR CO2 LASER SYSTEM (March 5, 1982)

Other clearances for product code LLF

  • K870773 — ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (July 10, 1987)
  • K864610 — CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (June 18, 1987)
  • K860977 — MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (October 16, 1986)

FDA data resources