510(k) K880988
K880988 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "PUDENDAL/LOCAL ANESTESIA BLOCK TRAY". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code KNE (Set, Anesthesia, Obstetric), a Class II device regulated under 21 CFR 884.5100. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1988
- Date Received
- March 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Anesthesia, Obstetric
- Device Class
- Class II
- Regulation Number
- 884.5100
- Review Panel
- OB
- Submission Type