510(k) K880988
- Device
- PUDENDAL/LOCAL ANESTESIA BLOCK TRAY
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K880988
- Product code
- KNE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-01
- Date received
- 1988-03-08
- Regulation
- 884.5100
- Classification name
- Set, Anesthesia, Obstetric
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 2618282
- 1319639
- 2243072
- 1423507
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K862358 | EPICATH | Hdc Corp. | 1986-07-07 |
Legacy Summary#
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FDA Review#
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