510(k) K880988

PUDENDAL/LOCAL ANESTESIA BLOCK TRAY by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KNE

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