510(k) K874867
K874867 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "CATR(TM)-H CARDIOTOMY HOLDER". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1988
- Date Received
- November 27, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type