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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853460
Device Name ENDO L 300 LIGHT, ILLUMINATING WOUND RECTRACTOR
Applicant
Heraeus, Inc.
Union Hill
Industrial Park
West Conshohocken,  PA  19428
Applicant Contact ROBERT STEINHAUSER
Correspondent
Heraeus, Inc.
Union Hill
Industrial Park
West Conshohocken,  PA  19428
Correspondent Contact ROBERT STEINHAUSER
Date Received08/19/1985
Decision Date 09/05/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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