510(k) K881859
K881859 is an FDA 510(k) premarket notification submitted by Weyerhaeuser Co. for the device "DRIPRIDE DISPOSABLE UNDERPAD". The FDA issued a decision of Substantially Equivalent on June 3, 1988. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Weyerhaeuser Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1988
- Date Received
- May 3, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bedding, Disposable, Medical
- Device Class
- Class I
- Regulation Number
- 880.6060
- Review Panel
- HO
- Submission Type