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FDA 510(k) Application Details - K971284
Device Classification Name
Retractor, All Types
More FDA Info for this Device
510(K) Number
K971284
Device Name
Retractor, All Types
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
Other 510(k) Applications for this Company
Contact
CHESTER MCCOY
Other 510(k) Applications for this Contact
Regulation Number
872.4565
More FDA Info for this Regulation Number
Classification Product Code
EIG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/1997
Decision Date
06/03/1997
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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