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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K880968
Device Name MODEL 2001 PHACOEMULSIFIER ASPIRATOR
Applicant
Mcghan Instrumed Corp.
3597 E. Supernal Cir.
Salt Lake City,  UT  84121
Applicant Contact EDWARD D FORRESTER
Correspondent
Mcghan Instrumed Corp.
3597 E. Supernal Cir.
Salt Lake City,  UT  84121
Correspondent Contact EDWARD D FORRESTER
Regulation Number886.4150
Classification Product Code
HQE  
Date Received03/08/1988
Decision Date 04/19/1988
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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