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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K912892
Device Name AUTO-VAC BIOPSY NEEDLE
Applicant
Angiomed GmbH & Co. Medizintechnik KG
Wachhausstr. 6
D-W 7500 Karlsruhe 41
Germany,  DE
Applicant Contact DR. F THEESEN
Correspondent
Angiomed GmbH & Co. Medizintechnik KG
Wachhausstr. 6
D-W 7500 Karlsruhe 41
Germany,  DE
Correspondent Contact DR. F THEESEN
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/01/1991
Decision Date 02/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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