FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROMOTOR
K Number: K023106
·
Decision Nov 5, 2002
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
2
Review Days
48
Basic Information
- Device Name
- PROMOTOR
- K Number
- K023106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CERES FERTILITY, INC.
- Date Received
- September 18, 2002
- Decision Date
- November 5, 2002
- Product Code
- MQL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by CERES FERTILITY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K024290 | PROMOTOR FINAL RINSE SPERM WASH MEDIUM | Mar 3, 2003 | Substantially Equivalent |