Pudendal/Local Anestesia Block Tray

FDA 510(k) K880988 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK880988

Submission

Device name
Pudendal/Local Anestesia Block Tray
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US
Received
March 8, 1988
Decision date
June 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNE – Set, Anesthesia, Obstetric
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5100
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code KNE

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K862358EpicathKNE · Traditional Hdc Corp.07/07/1986SE

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Questions and answers

When was Pudendal/Local Anestesia Block Tray cleared by the FDA?

Pudendal/Local Anestesia Block Tray (K880988) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 85 days after the submission was received.

What is the product code of K880988?

The FDA product code is KNE – Set, Anesthesia, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.5100.