510(k) K845010

CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH by Chesebrough-Pond'S U.S.A. Co. — Product Code EYQ

K845010 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH". The FDA issued a decision of Substantially Equivalent on January 15, 1985. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1985
Date Received
December 26, 1984
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