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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 K862343
Device Name VACUUM HANDLE MODEL I/A - 1
Applicant
CUTLER MEDICAL INSTRUMENTS
4607 KENNETH AVE.
SANTA MONICA,  CA  93455
Applicant Contact DAVID P CUTLER
Correspondent
CUTLER MEDICAL INSTRUMENTS
4607 KENNETH AVE.
SANTA MONICA,  CA  93455
Correspondent Contact DAVID P CUTLER
Regulation Number886.4150
Classification Product Code
HQE  
Date Received06/20/1986
Decision Date 07/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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