510(k) K842547
K842547 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "WET-STOP". The FDA issued a decision of Substantially Equivalent on Oct 19, 1984. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Palco Laboratories, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 1984
- Date Received
- Jul 2, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Alarm, Conditioned Response Enuresis
- Device Class
- Class II
- Regulation Number
- 876.2040
- Review Panel
- GU
- Submission Type
- 510(k) Exempt