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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 K011104
Device Name OSTEOBELL
Applicant
BIOPSYBELL S.A.S.
131 HIGHWOOD DR.
SOUTH GLASTONBURY,  CT  06073
Applicant Contact LUCIO IMPROTA
Correspondent
BIOPSYBELL S.A.S.
131 HIGHWOOD DR.
SOUTH GLASTONBURY,  CT  06073
Correspondent Contact LUCIO IMPROTA
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/11/2001
Decision Date 05/31/2001
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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