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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name distometer
510(k) Number K882575
Device Name DISTOMETER
Applicant
HAGG-STREIT SERVICE, INC.
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON,  DC  20036
Applicant Contact WILLIAM PENDERGAST
Correspondent
HAGG-STREIT SERVICE, INC.
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON,  DC  20036
Correspondent Contact WILLIAM PENDERGAST
Regulation Number886.1190
Classification Product Code
HMM  
Date Received06/22/1988
Decision Date 07/01/1988
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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