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FDA 510(k) Application Details - K980049
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K980049
Device Name
Unit, Operative Dental
Applicant
BLADHS PLAST AB
59 SWIFTWATER RD.
POCONO MANOR, PA 18349 US
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Contact
WILLIAM E MURPHY
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
01/06/1998
Decision Date
08/11/1998
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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