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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Ac-Powered
510(k) Number K952151
Device Name STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
Applicant
Storz
3365 Tree Ct. Industrial
Boulevard
St. Louis,  MO  63122
Applicant Contact AUDREY SWEARINGEN
Correspondent
Storz
3365 Tree Ct. Industrial
Boulevard
St. Louis,  MO  63122
Correspondent Contact AUDREY SWEARINGEN
Regulation Number886.4100
Classification Product Code
HQR  
Date Received05/08/1995
Decision Date 03/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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