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FDA 510(k) Application Details - K983223
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K983223
Device Name
Wrap, Sterilization
Applicant
BRASSELER USA I, L.P.
1679 KELLOGG SPRINGS DR.
ATLANTA, GA 30338 US
Other 510(k) Applications for this Company
Contact
COURTNEY S PARADICE
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/1998
Decision Date
01/14/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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