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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K991993
Device Name PHACOLASE ER: YAG LASER
Applicant
Aesculap-Meditec GmbH
2525 Mc Gaw Ave.
Irvine,  CA  92623 -9791
Applicant Contact WILLIAM T KELLEY
Correspondent
Aesculap-Meditec GmbH
2525 Mc Gaw Ave.
Irvine,  CA  92623 -9791
Correspondent Contact WILLIAM T KELLEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/14/1999
Decision Date 11/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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