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FDA 510(k) Application Details - K980739
Device Classification Name
Unit, Cryosurgical, Accessories
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510(K) Number
K980739
Device Name
Unit, Cryosurgical, Accessories
Applicant
ORASURE TECHNOLOGIES, INC.
1745 EATON AVE.
BETHLEHEM, PA 18018-1799 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
02/25/1998
Decision Date
05/26/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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