MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES

Syringe, Piston

SHERWOOD MEDICAL CO.

The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Sterile 12cc Syringes, W/wo Needles.

Pre-market Notification Details

Device IDK851089
510k NumberK851089
Device Name:MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
ClassificationSyringe, Piston
Applicant SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis,  MO  63103 -1625
ContactFrank J Fucile
CorrespondentFrank J Fucile
SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis,  MO  63103 -1625
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-18
Decision Date1985-04-12

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