510(k) K830774

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

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