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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 K020867
Device Name BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
Applicant
Worldwide Medical Technologies, LLC
426 Main St. N.
P.O. Box 505
Woodbury,  CT  06798
Applicant Contact GARY LAMOUREUX
Correspondent
Worldwide Medical Technologies, LLC
426 Main St. N.
P.O. Box 505
Woodbury,  CT  06798
Correspondent Contact GARY LAMOUREUX
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/18/2002
Decision Date 05/20/2002
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
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