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FDA 510(k) Application Details - K993125
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K993125
Device Name
Needle, Hypodermic, Single Lumen
Applicant
SAFETY MEDICAL SUPPLY INT,., INC.
135 BEAVER ST. 4TH FLOOR
WALTHAM, MA 02452-8424 US
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Contact
YOVETTE MUMFORD
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
09/20/1999
Decision Date
06/20/2000
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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