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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K012358
Device Name CHIBA NEEDLE
Applicant
Ispg, Inc.
517 Litchfield Rd.
New Milford,  CT  06776
Applicant Contact LORETTA F LUHMAN
Correspondent
Ispg, Inc.
517 Litchfield Rd.
New Milford,  CT  06776
Correspondent Contact LORETTA F LUHMAN
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/25/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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