WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE— 510(k) K011598
Substantially EquivalentIrvine Scientific Sales Co., Inc.
FDA 510(k) clearance K011598 for WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE, Substantially Equivalent on 2001-06-13. Applicant: Irvine Scientific Sales Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Irvine Scientific Sales Co., Inc.
- Product code
- Code MTW
- Device class
- Class 2
- Regulation
- 21 CFR 884.6170
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code MTW
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