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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 K935277
Device Name KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH
Applicant
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact SUSIE S CHEN
Correspondent
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Correspondent Contact SUSIE S CHEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/03/1993
Decision Date 09/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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