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Regulatory Strategy & Submission
Allura Medical Solution, Inc. has reliable experiences and positive working relationship with the FDA and related testing labs. Allura Medical Solution, Inc. works with you to do what is necessary to move the next milestone.
Allura Medical Solution, Inc. has reliable experiences and positive working relationship with the FDA and related testing labs. Allura Medical Solution, Inc. works with you to do what is necessary to move the next milestone.
- Submission Strategy Definition
- Product Analysis
- Product Classification
- Predicate Information Acquisition
- Medical Device Establishment Registration and Device Listing
- Pre-submission Service
- Pre-market Notification 510(k)
- Performance Data Analysis
- Predicate Comparison for Substantial Equivalence
- 510(k) Documentation & Submission
- 510(k) Follow up & Communication with FDA
- Special 510(k) & Special Control
- Other Submission Services
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