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FDA 510(k) Application Details - K960212
Device Classification Name
Syringe, Irrigating (Non Dental)
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510(K) Number
K960212
Device Name
Syringe, Irrigating (Non Dental)
Applicant
CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO, FL 32811 US
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Contact
RICHARD L ELLWOOD
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Regulation Number
880.6960
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Classification Product Code
KYZ
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Date Received
01/16/1996
Decision Date
04/01/1996
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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