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510(k) K830878

BINOCULAR LOUPE by Almore Intl., Inc. — Product Code HJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
March 18, 1983
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 Almore Intl., Inc.

  • K862851 — ALMORE FACE MASK (August 12, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

Other clearances for product code HJH

  • K874845 — MALIS SURGICAL LOUPES (December 23, 1987)
  • K863983 — EXETER OPERATING LOUPE (November 10, 1986)