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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name specula, ophthalmic
510(k) Number K964289
Device Name EYE FIXATION SPECULUM
Applicant
EYEFIX, INC.
12300 TWINBROOK PKWY.
ROCKVILLE,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
EYEFIX, INC.
12300 TWINBROOK PKWY.
ROCKVILLE,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.4350
Classification Product Code
HNC  
Date Received10/28/1996
Decision Date 12/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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