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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trephine, Manual, Ophthalmic
510(k) Number K861825
Device Name CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact CINDY PESTKA
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact CINDY PESTKA
Regulation Number886.4350
Classification Product Code
HRH  
Date Received05/12/1986
Decision Date 06/09/1986
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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