FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
SPERMGRAD, MODELS 10022/10063
K Number: K023403
·
Decision Dec 13, 2002
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
31
Review Days
64
Basic Information
- Device Name
- SPERMGRAD, MODELS 10022/10063
- K Number
- K023403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VITROLIFE SWEDEN AB
- Date Received
- October 10, 2002
- Decision Date
- December 13, 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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| K113786 | SPERMFREEZE SOLUTION | Oct 26, 2012 | Substantially Equivalent |
| K101003 | RAPIDVIT BLAST, RAPIDWARM BLAST | Dec 10, 2010 | Substantially Equivalent |
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| K081997 | PERFADEX WITH THAM | Oct 9, 2008 | Substantially Equivalent |
| K081115 | G-MOPS G5 SERIES | Sep 17, 2008 | Substantially Equivalent |