MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE

Tubes, Vials, Systems, Serum Separators, Blood Collection

SHERWOOD MEDICAL CO.

The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Trace Element Blood Collection Tube.

Pre-market Notification Details

Device IDK883320
510k NumberK883320
Device Name:MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis,  MO  63102 -1791
ContactCynthia Pestka
CorrespondentCynthia Pestka
SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis,  MO  63102 -1791
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-05
Decision Date1988-09-27

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