PUDENDAL/LOCAL ANESTESIA BLOCK TRAY

Set, Anesthesia, Obstetric

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Pudendal/local Anestesia Block Tray.

Pre-market Notification Details

• Device ID: K880988
• 510k Number: K880988
• Device Name: PUDENDAL/LOCAL ANESTESIA BLOCK TRAY
• Classification: Set, Anesthesia, Obstetric
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: Russell Arnsberger
• Correspondent: Russell Arnsberger; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: KNE
• CFR Regulation Number: 884.5100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-03-08
• Decision Date: 1988-06-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382904026030	K880988	000