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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Barrier, Protective
510(k) Number K091178
Device Name MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
Applicant
Mtp Medical Technical Promotion GmbH
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact YVONNE FERNANDEZ
Correspondent
Mtp Medical Technical Promotion GmbH
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact YVONNE FERNANDEZ
Regulation Number878.4370
Classification Product Code
MMP  
Date Received04/22/2009
Decision Date 07/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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