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Your 510(k)’s are authored and supported for one flat fee. Most submissions, if all supporting documentation is available, are often able to be completed and sent to the FDA in three weeks or less. This flat fee includes all follow-. Up correspondence with the FDA (Submission, registration and other fees from the FDA are not included in the above fees.). All other work can be on an hourly, not to exceed, or project basis. ZenStorming Solutions, LLC to discuss your project.
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ZenStorming Solutions, LLC. Lindenhurst, IL 60046. Call any time for a free consultation to discuss your 510(k) or Quality System concerns.
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Regulatory Solutions for Medical Device Manufacturers.
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