510(k) K840201
- Device
- EPIDURAL CATHETER TRAY
- Applicant
- ARIES MEDICAL, INC.
- 510(k) number
- K840201
- Product code
- MJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-02
- Date received
- 1984-01-19
- Regulation
- 866.3060
- Classification name
- Eia, Blastomyces Dermatitidis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MJL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923859 | PREMIER BLASTOMYCES | Meridian Diagnostics, Inc. | 1992-10-05 |
Legacy Summary#
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FDA Review#
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