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FDA 510(k) Application Details - K991946
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K991946
Device Name
Unit, Operative Dental
Applicant
STERILEX CORP.
7-I GWYNNS HILL COURT
OWINS MILLS, MD 21117 US
Other 510(k) Applications for this Company
Contact
SHIRA KRAMER
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/09/1999
Decision Date
09/03/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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