510(k) K873036
K873036 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "ATTENDS INCONTINENT BRIEF". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1988
- Date Received
- August 4, 1987
- 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