510(k) K031785
- Device
- MACROPORE CARDIO-WRAP (TS)
- Applicant
- MACROPORE BIOSURGERY, INC.
- 510(k) number
- K031785
- Product code
- OMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-04
- Date received
- 2003-06-10
- Regulation
- 870.3470
- Classification name
- Pericardial Patch To Facilitate Revision Surgeries
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH K KLEINHENZ
- Address
- 6740 Top Gun St. San Diego CA US 92121 92121
FDA Registration Numbers#
- 1047429
- 3004661493
- 2024024
Source Documents#
Legacy Summary#
summary
FDA Review#
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