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

TUMBLER, GENERAL MEDICAL MEDI-PAK

K Number: K760491 · Decision Sep 15, 1976
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
13
Review Days
23

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Basic Information

Device Name
TUMBLER, GENERAL MEDICAL MEDI-PAK
K Number
K760491
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5725
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Landmark Plastics
Date Received
August 23, 1976
Decision Date
September 15, 1976
Product Code
LDR
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
LDR Controller, Infusion, Intravascular, Electronic

Similar 510(k) Clearances

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

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Other Clearances by Landmark Plastics

K Number Device Name
K760496 CUP, DISPOSABLE SPECIMEN
K760493 DISH, SOAP
K760492 BASIN, LARGE OR SMALL
K760490 BEDPAN, GENERAL MEDICAL MEDI-PAK
K760552 THERMOMETER STAND AND DUST COVER
K760494 BASIN, ROUND WASH
K760517 CUP, DISPOSABLE MEDICINE
K760497 TRAY, SERVICE
K760495 BASIN, RECTANGULAR WASH
K760548 CARAFE AND LINER
Search all 13 clearances from Landmark Plastics →