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FDA 510(k) Application Details - K972450
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K972450
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
ENDIUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
CYNTHIA J NOLTE
Other 510(k) Applications for this Contact
Regulation Number
874.4760
More FDA Info for this Regulation Number
Classification Product Code
EOB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/1997
Decision Date
11/21/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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