510(k) K854408

ADULT ABSORBENT INCONTINENT BRIEF by Weyerhaeuser Co. — Product Code EYQ

K854408 is an FDA 510(k) premarket notification submitted by Weyerhaeuser Co. for the device "ADULT ABSORBENT INCONTINENT BRIEF". The FDA issued a decision of Substantially Equivalent on November 19, 1985. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Weyerhaeuser Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1985
Date Received
November 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Garment, Protective, For Incontinence
Device Class
Class I
Regulation Number
876.5920
Review Panel
GU
Submission Type