COUGH PILLOW

Binder, Elastic

CUSTOM HOSPITALS PRODUCTS

The following data is part of a premarket notification filed by Custom Hospitals Products with the FDA for Cough Pillow.

Pre-market Notification Details

Device IDK893809
510k NumberK893809
Device Name:COUGH PILLOW
ClassificationBinder, Elastic
Applicant CUSTOM HOSPITALS PRODUCTS P.O. BOX 17002 Portland,  OR  97217
ContactBill Sprague
CorrespondentBill Sprague
CUSTOM HOSPITALS PRODUCTS P.O. BOX 17002 Portland,  OR  97217
Product CodeKMO  
CFR Regulation Number880.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-22
Decision Date1989-08-28

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