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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chair, Ophthalmic, Ac-Powered
510(k) Number K870112
Device Name STORZ ENT/OPHTHALMIC MAXI CHAIR
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 Number886.1140
Classification Product Code
HME  
Date Received01/12/1987
Decision Date 02/12/1987
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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