510(k) K900207
- Device
- EPICARDIA 4000
- Applicant
- MEDICOMP, INC.
- 510(k) number
- K900207
- Product code
- DST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-31
- Date received
- 1990-01-16
- Regulation
- 870.3260
- Classification name
- Clip, Vena-cava
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID J PLUMMER
- Address
- 7845 Ellis Rd. West Melbourne FL US 32904 32904
FDA Registration Numbers#
- 3021559257
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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