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FDA 510(k) Application Details - K991857
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K991857
Device Name
Handpiece, Air-Powered, Dental
Applicant
ELECTRO MEDICAL SYSTEMS, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
CYNTHIA J.M. NOLTE
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Regulation Number
872.4200
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Classification Product Code
EFB
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More FDA Info for this Product Code
Date Received
06/01/1999
Decision Date
10/07/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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