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FDA 510(k) Application Details - K100125
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K100125
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
VISION-SCIENCES, INC.
40 RAMLAND RD. SOUTH
ORANGEBURG, NY 10962 US
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Contact
LILLIAN QUINTERO
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
01/19/2010
Decision Date
02/25/2010
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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