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510(k) K892348

MAGNILINK SYSTEM 201 by Coburn Optical Ind., Inc. — Product Code HJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1989
Date Received
April 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Reading, Television, Closed-Circuit
Device Class
Class I
Regulation Number
886.5820
Review Panel
OP
Submission Type

Other clearances by Coburn Optical Ind., Inc.

  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)
  • K892349 — MAGNILINK SYSTEM 209 (May 26, 1989)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)
  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)
  • K862188 — IRRIGATION & ASPIRATION/VITRECTOMY DEVICE (August 21, 1986)
  • K853457 — COBURN I/A SYSTEM (October 15, 1985)
  • K821737 — DISP. MICROSURGICAL KNIVES (July 2, 1982)
  • K812441 — DI-CROWN (October 6, 1981)
  • K803159 — AUTOMATED PERIMETERS (February 4, 1981)
  • K801659 — BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE (September 9, 1980)

Other clearances for product code HJG

  • K933633 — LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE (February 22, 1994)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K920069 — MAGNI-CAM (March 2, 1992)
  • K892349 — MAGNILINK SYSTEM 209 (May 26, 1989)
  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)
  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)