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

ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.

K Number: K801558 · Decision Jul 28, 1980
Classifications
1
FEI Numbers
242
Registration Numbers
243
Same Product Code
648
Applicant Total
70
Review Days
20

Basic Information

Device Name
ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.
K Number
K801558
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5980
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
Date Received
July 8, 1980
Decision Date
July 28, 1980
Product Code
KNT
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
KNT Tubes, Gastrointestinal (And Accessories)

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K951260 URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
K944614 MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
K932295 NON-BALLOON REPLACEMENT GASTROSTOMY KIT
K935045 BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K923002 ENTEROCLYSIS TUBE
K934193 CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
K922987 LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
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