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FDA 510(k) Application Details - K970916
Device Classification Name
Lavage, Jet
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510(K) Number
K970916
Device Name
Lavage, Jet
Applicant
GLOBAL MEDICAL PRODUCTS, INC.
1725 SOUTH RAINBOW BLVD., #25
LAS VEGAS, NV 89146 US
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Contact
TONYA BALABAN
Other 510(k) Applications for this Contact
Regulation Number
880.5475
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Classification Product Code
FQH
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More FDA Info for this Product Code
Date Received
03/12/1997
Decision Date
06/20/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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