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510(k) K893809

Device
COUGH PILLOW
Applicant
CUSTOM HOSPITALS PRODUCTS
510(k) number
K893809
Product code
KMO  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-28
Date received
1989-05-22
Regulation
880.5160
Classification name
Binder, Elastic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BILL SPRAGUE
Address
P.O. Box 17002 Portland OR US 97217 97217

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K9218524 SURE TM RECTAL TUBEBoston Pacific Medical, Inc.1993-10-08
K883214THORACIC SUPPORT SYSTEMStorer Medical Products1989-01-17
K882592HEART HUGGER STERNUM SUPPORT HARNESSGeneral Cardiac Technology, Inc.1988-09-20
K792629STERILIZATION PROCESS/T-BINDERProcter & Gamble Mfg. Co.1980-01-11

Legacy Summary#

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FDA Review#

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