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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K945809
Device Name MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
Applicant
SHERWOOD MEDICAL CO.
ROSECRANS MEMORIAL AIRPORT
ST. JOSEPH,  MO  64503
Applicant Contact K M KROEHNKE
Correspondent
SHERWOOD MEDICAL CO.
ROSECRANS MEMORIAL AIRPORT
ST. JOSEPH,  MO  64503
Correspondent Contact K M KROEHNKE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/28/1994
Decision Date 03/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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