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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name loupe, binocular, low power
510(k) Number K830878
Device Name BINOCULAR LOUPE
Applicant
ALMORE INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ALMORE INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.5120
Classification Product Code
HJH  
Date Received03/18/1983
Decision Date 04/06/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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