Traditional 510k application - Polymeric Surgical Mesh

Healthmatrixtm

Macroporous

Polypropylene surgical Mesh

510(k) Premarket notification

Traditional 510(k)

By: Group 2

Ganesh Balachandar

Adriana Gavrilciuc

Nikhil Khanna

Gaurav Molankar

Thinn Soe

Healthmatrix

H M T

TableoSection 1

Section 2

Section 3

Section 4

Section 5

Section 6

Section 7

Section 8

Section 9

Section 10

Section 11

Section 12

Section 13

Section 14

Section 15

Section 16

HealthMatrixT

MacroporousTraditional 51

ofConten– 510(k) Cove

– Indications

– 510(k) Sum

– Class III Sum

– Financial C

– Declaration

– Executive S

– Device Des

– Substantial

0 – Proposed

1 – Sterilizatio

2 – Biocompa

3 – Performa

4 – Package V

5 – Risk Analy

6 – List of App

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Company Confidential

H M T

ListofTable 1:

Table 2:

Table 3:

Table 4:

Table 5:

Table 6:

Table 7:

Table 8:

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Figure 2:

Figure 3:

Figure 4:

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H M T

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Section

12.1 Gen

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ndards. Our eed oil.

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Documents

Traditional 510k application - Polymeric Surgical Mesh