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Re: jburby777 post# 137881

Thursday, 05/24/2018 10:39:37 AM

Thursday, May 24, 2018 10:39:37 AM

Post# of 278380
No, KBLB would be providing raw materials for a "Variable cost" yet to be determined for the "Medical Manufactures" and they are the ones that develop the product, submit the application to the FDA. Once the FDA clears the prototype application to include schematics, drawings/diagrams and documentation, the finished product must undergo the FDA 510-K approval process. Upon successful completion of the 510-K, the FDA will grant a license/certificate to manufacture, sell and distribute that "Medical Product" for public consumption and or use.

Hope that helps clarify KBLB is in great shape.

FYI, I was a Bio-Medical Engineer for a 510-K application at a Major Medical Corp here in the U.S.A.

Regards

Sunny:>)))
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