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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 Ave., NW
Washington,  DC  20036
Applicant Contact WILLIAM PENDERGAST
Correspondent
Hagg-Streit Service, Inc.
1050 Connecticut Ave., NW
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
Predetermined Change
Control Plan Authorized		 No
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