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FDA 510(k) Application Details - K001765
Device Classification Name
Source, Brachytherapy, Radionuclide
More FDA Info for this Device
510(K) Number
K001765
Device Name
Source, Brachytherapy, Radionuclide
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING, PA 19606 US
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Contact
LINDA F TEXTER
Other 510(k) Applications for this Contact
Regulation Number
892.5730
More FDA Info for this Regulation Number
Classification Product Code
KXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2000
Decision Date
09/07/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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