510(k) K862358
- Device
- EPICATH
- Applicant
- HDC CORP.
- 510(k) number
- K862358
- Product code
- KNE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-07
- Date received
- 1986-06-23
- 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
- WILLIAM J SCHRODER
- Address
- 2551 Casey Ave. Mountain View CA US 94043 94043
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 |
|---|---|---|---|
| K880988 | PUDENDAL/LOCAL ANESTESIA BLOCK TRAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-06-01 |
Legacy Summary#
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FDA Review#
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