FDA 510(k) Application Details - K952578

Device Classification Name Otoscope

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510(K) Number K952578
Device Name Otoscope
Applicant WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY US
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Contact CRAIG MULLIN
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Regulation Number 874.4770

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Classification Product Code ERA
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Date Received 06/05/1995
Decision Date 07/10/1995
Decision SE - Substantially Equivalent
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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