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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Binder, Elastic
510(k) Number K893809
Device Name COUGH PILLOW
Applicant
Custom Hospitals Products
P.O. Box 17002
Portland,  OR  97217
Applicant Contact BILL SPRAGUE
Correspondent
Custom Hospitals Products
P.O. Box 17002
Portland,  OR  97217
Correspondent Contact BILL SPRAGUE
Regulation Number880.5160
Classification Product Code
KMO  
Date Received05/22/1989
Decision Date 08/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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