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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K924212
Device Name STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
Applicant
Stryker Corp.
210 Baypointe Pkwy.
San Jose,  CA  95134
Applicant Contact LISA SCHWEITZER
Correspondent
Stryker Corp.
210 Baypointe Pkwy.
San Jose,  CA  95134
Correspondent Contact LISA SCHWEITZER
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received08/20/1992
Decision Date 07/07/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
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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