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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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More FDA Info for this Product Code
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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