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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 K913504
Device Name STORZ MICRO CUTTER 25 GAUGE PACK
Applicant
STORZ
3365 TREE COURT INDUSTRIAL
BOULEVARD
ST. LOUIS,  MO  63122
Applicant Contact MICHAEL T TAGGART
Correspondent
STORZ
3365 TREE COURT INDUSTRIAL
BOULEVARD
ST. LOUIS,  MO  63122
Correspondent Contact MICHAEL T TAGGART
Regulation Number886.4150
Classification Product Code
HQE  
Date Received08/07/1991
Decision Date 02/21/1992
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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