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FDA 510(k) Application Details - K023487
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K023487
Device Name
Unit, Cryosurgical, Accessories
Applicant
ORASURE TECHNOLOGIES, INC.
150 WEBSTER ST.
BETHELEHEM, PA 18015-1389 US
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Contact
R. SAM NIEDBALA
Other 510(k) Applications for this Contact
Regulation Number
878.4350
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Classification Product Code
GEH
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More FDA Info for this Product Code
Date Received
10/17/2002
Decision Date
03/20/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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