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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K965127
Device Name DGH MODEL 9000
Applicant
Dgh Technology, Inc.
110 Summit Dr., Suite B
Exton,  PA  19341
Applicant Contact EARL W HENDERSON
Correspondent
Dgh Technology, Inc.
110 Summit Dr., Suite B
Exton,  PA  19341
Correspondent Contact EARL W HENDERSON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/23/1996
Decision Date 03/17/1997
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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