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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Scleral
510(k) Number K854507
Device Name STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact DAN REGAN
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact DAN REGAN
Regulation Number886.4155
Classification Product Code
LXP  
Date Received11/12/1985
Decision Date 02/07/1986
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
Recalls CDRH Recalls
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