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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Biopsy
510(k) Number K895885
Device Name AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING
Applicant
National-Standard Co.
4445-360 SW 35th Ter.
Gainesville,  FL  32608
Applicant Contact ROBINSON
Correspondent
National-Standard Co.
4445-360 SW 35th Ter.
Gainesville,  FL  32608
Correspondent Contact ROBINSON
Regulation Number876.1075
Classification Product Code
FCI  
Date Received10/05/1989
Decision Date 02/09/1990
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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