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FDA 510(k) Application Details - K955088
Device Classification Name
Locator, Root Apex
More FDA Info for this Device
510(K) Number
K955088
Device Name
Locator, Root Apex
Applicant
AMERICAN MEDICAL & DENTAL CORP.
1236 BRACE RD.
BUILDING B
CHERRY HILL, NJ 08034 US
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Contact
JEROME FARBER
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/1995
Decision Date
07/10/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K955088
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