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FDA 510(k) Application Details - K083553
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K083553
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
SCHOELLY IMAGING, INC.
200 homer avenue
Ashland, MA 01721 US
Other 510(k) Applications for this Company
Contact
F. DAVID ROTHKOPF
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
12/01/2008
Decision Date
01/16/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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