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FDA 510(k) Application Details - K132315
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K132315
Device Name
Unit, Operative Dental
Applicant
ERGONOMIC PRODUCTS, INC.
240 ANNETTE AVE
WOONSOCKET, RI 02895 US
Other 510(k) Applications for this Company
Contact
RENEE GOULD
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
07/25/2013
Decision Date
04/18/2014
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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