FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

KITS AND TRAYS FOR DIALYSIS USE

K Number: K871630 · Decision May 26, 1987
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
5
Applicant Total
2
Review Days
29

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Basic Information

Device Name
KITS AND TRAYS FOR DIALYSIS USE
K Number
K871630
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
876.5820
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
Dove Medical Supplies
Date Received
April 27, 1987
Decision Date
May 26, 1987
Product Code
FKG
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
FKG Tray, Start/Stop (Including Contents), Dialysis

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (FKG), ordered by most recent decision date.

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Other Clearances by Dove Medical Supplies

K Number Device Name
K883068 HEMODIALYSIS CONCENTRATES