510(k) K895110
- Device
- MAESTRO PACEMAKER TEST MAGNET
- Applicant
- CARDIAC CONTROL SYSTEMS, INC.
- 510(k) number
- K895110
- Product code
- DTG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-09-26
- Date received
- 1989-08-15
- Regulation
- 870.3690
- Classification name
- Magnet, Test, Pacemaker
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT MINDREBO
- Address
- 3 Commerce Blvd. Palm Coast FL US 32164 32164
FDA Registration Numbers#
- 1000165971
- 2017865
- 3008159616
- 9610139
- 2182208
- 1644487
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTG #
Legacy Summary#
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FDA Review#
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