The following data is part of a premarket notification filed by Custom Hospitals Products with the FDA for Cough Pillow.
Device ID | K893809 |
510k Number | K893809 |
Device Name: | COUGH PILLOW |
Classification | Binder, Elastic |
Applicant | CUSTOM HOSPITALS PRODUCTS P.O. BOX 17002 Portland, OR 97217 |
Contact | Bill Sprague |
Correspondent | Bill Sprague CUSTOM HOSPITALS PRODUCTS P.O. BOX 17002 Portland, OR 97217 |
Product Code | KMO |
CFR Regulation Number | 880.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-22 |
Decision Date | 1989-08-28 |