An Abbreviated 510(k) relies on the use of guidance documents, special controls and recognized standards in addition to substantial equivalence to demonstrate device safety and effectiveness.
 
 
GEAMR can help you determine if this type of submission is appropriate for your device. We can also help you assess the conformance of your device to guidance documents and/or special controls, assist in the preparation of declarations of conformity to recognized standards and assist in preparing the documentation required for submission.