FDA 510(k) Application Details - K934918

Device Classification Name Endoscope And/Or Accessories

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510(K) Number K934918
Device Name Endoscope And/Or Accessories
Applicant PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG, NY US
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Contact PAUL SILVA
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Regulation Number 876.1500

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Classification Product Code KOG
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Date Received 10/15/1993
Decision Date 02/07/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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