NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
FDA 510(k) clearance K990941 · decided 1999-07-14
Clearance details
- K-number
- K990941
- Device name
- NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
- Applicant
- Humagen Fertility Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-22
- Decision date
- 1999-07-14
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.