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FDA 510(k) Application Details - K960065
Device Classification Name
Instrument, Biopsy
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510(K) Number
K960065
Device Name
Instrument, Biopsy
Applicant
BAUER MEDICAL, INC.
13191 56TH COURT
SUITE 106
CLEARWATER, FL 34620 US
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Contact
PAT LAMB
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
01/05/1996
Decision Date
04/05/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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