FDA 510(k) Application Details - K050797

Device Classification Name Syringe, Irrigating (Non Dental)

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510(K) Number K050797
Device Name Syringe, Irrigating (Non Dental)
Applicant SHIPPERT MEDICAL TECHNOLOGIES CORP.
6248 SOUTH TROY CIRCLE
UNIT A
CENTENNIAL, CO 80111 US
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Contact SARAH LAKE
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Regulation Number 880.6960

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Classification Product Code KYZ
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Date Received 03/29/2005
Decision Date 07/13/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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