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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K090818
Device Name KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
Applicant
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact MONIKA CAMPBELL
Correspondent
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact MONIKA CAMPBELL
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/25/2009
Decision Date 08/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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