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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Ac-Powered
510(k) Number K900913
Device Name ADLER DISPOSABLE BIPOLAR CORD
Applicant
Adler Instrument Co.
6191 Atlantic Blvd.
Norcross,  GA  30071
Applicant Contact NORMAN BLACK
Correspondent
Adler Instrument Co.
6191 Atlantic Blvd.
Norcross,  GA  30071
Correspondent Contact NORMAN BLACK
Regulation Number886.4115
Classification Product Code
HQO  
Date Received02/27/1990
Decision Date 04/04/1990
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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