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510(k) K801659

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE by Coburn Optical Ind., Inc. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
July 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Coburn Optical Ind., Inc.

  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)
  • K892348 — MAGNILINK SYSTEM 201 (May 26, 1989)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)
  • K892349 — MAGNILINK SYSTEM 209 (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)

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  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
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  • K162684 — SL 220 (May 31, 2017)
  • K163564 — SLIT LAMP SL-2000 (May 19, 2017)