510(k) K915741
- Device
- DISPOSABLE MONOPLAR MEDDLE ELECTRODES
- Applicant
- DANTEC MEDICAL, INC.
- 510(k) number
- K915741
- Product code
- GXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-08
- Date received
- 1991-12-20
- Regulation
- 882.4600
- Classification name
- Leukotome
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD D MANTHEI
- Address
- 1575 Eye St. NW Washington DC US 20005 20005
Source Documents#
Legacy Summary#
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FDA Review#
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