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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K852331
Device Name SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC
Applicant
Scholten Surgical Instruments, Inc.
707 Warrington Ave.
Redwood City,  CA  94063
Applicant Contact JACOBUS SCHOLTEN
Correspondent
Scholten Surgical Instruments, Inc.
707 Warrington Ave.
Redwood City,  CA  94063
Correspondent Contact JACOBUS SCHOLTEN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received05/31/1985
Decision Date 08/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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