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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 K913261
Device Name DWYER EYE SYSTEMS ASPIRATION UNIT
Applicant
Spectracare, Inc.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact LYNNE ARONSON
Correspondent
Spectracare, Inc.
C/O Medical Device Consultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact LYNNE ARONSON
Regulation Number886.4150
Classification Product Code
HQE  
Date Received07/23/1991
Decision Date 01/30/1992
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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