510(k) K993140
- Device
- WATER FOR TISSUE CULTURE, MODELS 1500
- Applicant
- CONCEPTION TECHNOLOGIES
- 510(k) number
- K993140
- Product code
- MTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-08-02
- Date received
- 1999-09-20
- Regulation
- 884.6170
- Classification name
- System, Water, Reproduction, Assisted, And Purification
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GREG HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MTW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011598 | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE | Irvine Scientific Sales Co., Inc. | 2001-06-13 |
Legacy Summary#
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FDA Review#
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