FDA 510(k) Application Details - K960876

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K960876
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant FIVE STAR MEDICAL, INC.
RR2 BOX 418 UNION RD.
HOLLAND, MA 01521-9721 US
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Contact BEVERLY J STEWART
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 03/04/1996
Decision Date 05/08/1996
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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