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510(k) K820375

PLASTIC OR GLASS MAGNIFIER by Gazelle Corp. — Product Code HJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
February 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnifier, Hand-Held, Low-Vision
Device Class
Class I
Regulation Number
886.5540
Review Panel
OP
Submission Type

Other clearances by Gazelle Corp.

  • K844716 — MAGNIFYING SPECTACLES W/PLASTIC LENSES (January 3, 1985)