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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K952443
Device Name KARL STORZ ENDOSCOPY POWDER BLOWER
Applicant
Karl Storz Endoscopy-America, Inc.
91 Carpenter Hill Rd.
Charlton,  MA  01507 -3578
Applicant Contact BETTY M JOHNSON
Correspondent
Karl Storz Endoscopy-America, Inc.
91 Carpenter Hill Rd.
Charlton,  MA  01507 -3578
Correspondent Contact BETTY M JOHNSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/25/1995
Decision Date 08/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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