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510(k) K871006

Device
EDCOOL AND EDCOOL JR. INSTANT COLD PACK
Applicant
ADVANTAGE CREDIT SERVICES, INC.
510(k) number
K871006
Product code
IMP  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-25
Date received
1987-03-13
Regulation
890.3920
Classification name
Cushion, Wheelchair
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HOWARD J GERSON
Address
P.O. Box 768 Kansas City MO US 64141 64141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890653ULTIMA WHEELCHAIR CUSHIONClark Pillow Co., Inc.1989-02-28

Legacy Summary#

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FDA Review#

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