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510(k) K863983

EXETER OPERATING LOUPE by Exeter Instruments, Inc. — Product Code HJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Loupe, Binocular, Low Power
Device Class
Class I
Regulation Number
886.5120
Review Panel
OP
Submission Type

Other clearances by Exeter Instruments, Inc.

  • K810817 — EXETER OPERATING LOUPE (April 23, 1981)

Other clearances for product code HJH

  • K874845 — MALIS SURGICAL LOUPES (December 23, 1987)
  • K830878 — BINOCULAR LOUPE (April 6, 1983)