NON STERILE PARENTERAL SUPPLY KIT

Syringe, Piston

INTERMED, INC.

The following data is part of a premarket notification filed by Intermed, Inc. with the FDA for Non Sterile Parenteral Supply Kit.

Pre-market Notification Details

Device IDK900857
510k NumberK900857
Device Name:NON STERILE PARENTERAL SUPPLY KIT
ClassificationSyringe, Piston
Applicant INTERMED, INC. 15 WHITE LAKE RD. Sparta,  NJ  07871
ContactNorm Ruedt
CorrespondentNorm Ruedt
INTERMED, INC. 15 WHITE LAKE RD. Sparta,  NJ  07871
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-23
Decision Date1990-05-22

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