WATER FOR TISSUE CULTURE, MODELS 1500
FDA 510(k) clearance K993140 · decided 2000-08-02
Clearance details
- K-number
- K993140
- Device name
- WATER FOR TISSUE CULTURE, MODELS 1500
- Applicant
- Conception Technologies
- Decision
- Substantially Equivalent
- Date received
- 1999-09-20
- Decision date
- 2000-08-02
- Days to decision
- 317 days
- Clearance type
- Traditional
- Product code
- MTW
- Device class
- 2
- Regulation number
- 884.6170
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Irvine, 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 ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE (K011598) | Irvine Scientific Sales Co., Inc. | 2001-06-13 |
Recalls involving this device
No recalls on record reference this clearance.