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FY 2009 Device Review User Fees (U.S. Dollars)
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510(k) :
. \' b* `5 [' c/ c5 R0 ]) O7 s3 gApplication Standard Fee7 [2 Q; ?+ D+ }: _5 i2 P g# C
$3,693
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Small Business (≤$100 million in
! _% n. n2 Z( k1 x7 Y5 igross receipts or sales) Fee% o1 T* Y' W$ W3 E/ o V( p; M+ e
$1,8473 ~' m3 ?! G, i
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如果你符合 small business 资格认定标准,又有很多 510k 要申请,强烈建议去申请 small business ,. w4 ^2 g. Q S7 D) g8 F1 g
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FY 2009 Establishment Registration Fee is $1,851 U.S. Dollars,8 ^4 h9 g* d4 }+ S3 E
以前注册不用钱.4 {( l' Y+ S- Q8 q
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" Q" s2 o; z5 A' `以上费用为2009 年最新费用,FDA会适时调整收费标准 |
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