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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Examining/Treatment, Ent
510(k) Number K911901
Device Name MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
Applicant
Stortz
3365 Tree Ct. Ind. Blvd.
Saint Louis,  MO  63122
Applicant Contact MICHAEL T.TAGGERT
Correspondent
Stortz
3365 Tree Ct. Ind. Blvd.
Saint Louis,  MO  63122
Correspondent Contact MICHAEL T.TAGGERT
Regulation Number874.5300
Classification Product Code
ETF  
Date Received04/29/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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