510(k) K895881
- Device
- MOTIONSPECT
- Applicant
- BALTIMORE THERAPEUTIC EQUIPMENT CO.
- 510(k) number
- K895881
- Product code
- LXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-10
- Date received
- 1989-10-05
- Regulation
- 510(k) Premarket Notification
- Classification name
- Column, Adsorption, Low Density, Lipoprotein
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAY III
- Address
- 7455-L New Ridge Rd. Hanover MD US 21076 21076
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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