FDA 510(k) Application Details - K962688

Device Classification Name Dilator, Esophageal, Ent

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510(K) Number K962688
Device Name Dilator, Esophageal, Ent
Applicant BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH, MA 01581 US
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Contact STUART K MONTGOMERY
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Regulation Number 874.4420

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Classification Product Code KCF
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Date Received 07/11/1996
Decision Date 07/25/1996
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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