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No Yes: Decision Substantially Equivalent

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31 views1 page

No Yes: Decision Substantially Equivalent

Uploaded by

umesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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510K-Notification

Comparing new device


(N/D) to predicate

Does N/D No Do the difference Yes


N/D have new
have same affect the safety
intended use
indication for use and effectiveness

No
Yes

Does N/D
No New characteristics Yes
have same
affect safety and
technological
effectiveness ?
characteristics

New characteristics Yes


Yes No rise new type of
safety and
effectiveness ?
Are descriptive
No
characteristics No
precise enough to
ensure SE

Do scientificmethod No
Yes exists for assessing new
No Performance characteristics ?
data
available?
Yes

performance Are performance


Yes No
data data available to
required access new characteristics

Yes
Performance
Performance Yes data required
data demonstrate Performance No
SE ? data demonstrate
SE ?

No
Yes

Decision Decision Decision


NSE Substantially NSE
Equivalent

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