510(k) K845010
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