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510(k) Data Aggregation

K Number

K011598

Device Name

WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE

Manufacturer

IRVINE SCIENTIFIC SALES CO., INC.

Date Cleared

2001-06-13

(20 days)

Product Code

MTW

Regulation Number

884.6170

Intended Use

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water. Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures. Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.

Device Description

Water for Assisted Reproductive Technologies (A.R.T.) Use is a water intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water. Water for Assisted Reproductive Technologies (A.R.T.) Use is highly purified water of USP WFI grade.

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K Number

K993140

Device Name

WATER FOR TISSUE CULTURE, MODELS 1500

Manufacturer

CONCEPTION TECHNOLOGIES

Date Cleared

2000-08-02

(317 days)

Product Code

MTW

Regulation Number

884.6170

Intended Use

Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures. It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.

Device Description

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