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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 K854402
Device Name THE NEW MCINTYRE I.A. HANDPIECE
Applicant
Microsurgical Technology, Inc.
723 B 9th Ave.
Kirkland,  WA  98033
Applicant Contact NILSSON
Correspondent
Microsurgical Technology, Inc.
723 B 9th Ave.
Kirkland,  WA  98033
Correspondent Contact NILSSON
Regulation Number886.4350
Classification Product Code
HMX  
Date Received10/31/1985
Decision Date 12/30/1985
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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