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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K960007
Device Name STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
Applicant
Storz
3365 Tree Court Industrial
Boulevard
St. Louis,  MO  63122
Applicant Contact AUDREY SWEARINGEN
Correspondent
Storz
3365 Tree Court Industrial
Boulevard
St. Louis,  MO  63122
Correspondent Contact AUDREY SWEARINGEN
Regulation Number876.1500
Classification Product Code
MPA  
Date Received01/02/1996
Decision Date 03/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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