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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, ophthalmic
510(k) Number K930113
Device Name KIRWAN IRRIGATION/ASPIRATION HANDPIECE
Applicant
KIRWAN SURGICAL PRODUCTS, INC.
83 E. WATER ST.
P.O. BOX 545
ROCKLAND,  MA  02370
Applicant Contact DANA A OLIVER
Correspondent
KIRWAN SURGICAL PRODUCTS, INC.
83 E. WATER ST.
P.O. BOX 545
ROCKLAND,  MA  02370
Correspondent Contact DANA A OLIVER
Regulation Number886.4350
Classification Product Code
HMX  
Date Received01/11/1993
Decision Date 02/17/1994
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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