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510(k) K830774

BINOCULAR MAGNIFIER 2X by Almore Intl., Inc. — Product Code HKC

K830774 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "BINOCULAR MAGNIFIER 2X". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code HKC (Spectacle Microscope, Low-Vision), a Class I device regulated under 21 CFR 886.5540. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
March 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectacle Microscope, Low-Vision
Device Class
Class I
Regulation Number
886.5540
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)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

FDA data resources