510(k) K881859

DRIPRIDE DISPOSABLE UNDERPAD by Weyerhaeuser Co. — Product Code KME

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