WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
FDA 510(k) clearance K011598 · decided 2001-06-13
Clearance details
- K-number
- K011598
- Device name
- WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
- Applicant
- Irvine Scientific Sales Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-24
- Decision date
- 2001-06-13
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- MTW
- Device class
- 2
- Regulation number
- 884.6170
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WATER FOR TISSUE CULTURE, MODELS 1500 (K993140) | Conception Technologies | 2000-08-02 |
Recalls involving this device
No recalls on record reference this clearance.