FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

AIMED DISPOSABLE SYRINGE, VARIOUS SIZES

K Number: K842227 · Decision Jul 23, 1984
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
6
Review Days
48

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Basic Information

Device Name
AIMED DISPOSABLE SYRINGE, VARIOUS SIZES
K Number
K842227
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Tech-Cons Ltd., Intl.
Date Received
June 5, 1984
Decision Date
July 23, 1984
Product Code
FMF
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FMF Syringe, Piston

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Other Clearances by Tech-Cons Ltd., Intl.

K Number Device Name
K843117 GREEN CROSS URINARY DRAINAGE BAG
K843035 SANG-A PETROLATUM GAUZE USP STERILE
K842228 AIMED FOLEY CATHETER VARIOUS SIZES
K842255 AIMED SCALP VEIN SET VARIOUS
K842230 AIMED DISPOS. INJECTION NEEDLE