FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
K Number: K172197
·
Decision Oct 13, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
14
Review Days
84
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Basic Information
- Device Name
- SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
- K Number
- K172197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origio A/S
- Date Received
- July 21, 2017
- Decision Date
- October 13, 2017
- 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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