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

COMPAT ENTERAL FEED PUMP 199235 & 199240

K Number: K891575 · Decision Sep 12, 1989
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
20
Review Days
176

Basic Information

Device Name
COMPAT ENTERAL FEED PUMP 199235 & 199240
K Number
K891575
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5725
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
SANDOZ NUTRITION
Date Received
March 20, 1989
Decision Date
September 12, 1989
Product Code
LZH
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
LZH Pump, Infusion, Enteral

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K940555 SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
K940556 SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K924308 GASTROPORT II
K923983 PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT
K915308 PEG GASTROSTOMY TUBE KIT
K920493 PEG PREP TRAY
K913407 NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE
K914492 GASTROINTESTINAL TUBE AND ACCESSORIES
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