510(k) K893809
K893809 is an FDA 510(k) premarket notification submitted by Custom Hospitals Products for the device "COUGH PILLOW". The FDA issued a decision of Substantially Equivalent on August 28, 1989. The device falls under product code KMO (Binder, Elastic), a Class I device regulated under 21 CFR 880.5160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1989
- Date Received
- May 22, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Binder, Elastic
- Device Class
- Class I
- Regulation Number
- 880.5160
- Review Panel
- HO
- Submission Type