510(k) K901531
- Device
- PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
- Applicant
- PIONEERING TECHNOLOGIES, INC.
- 510(k) number
- K901531
- Product code
- DNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-20
- Date received
- 1990-03-22
- Regulation
- 862.3380
- Classification name
- Thin Layer Chromatography, Ethosuximide
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WRIGHT,PHD
- Address
- 3900 Youngfield St. Wheat Ridge CO US 80033 80033
FDA Registration Numbers#
- 1723241
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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