FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAPERSOL
K Number: K080432
·
Decision Aug 8, 2008
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
42
Applicant Total
6
Review Days
171
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Basic Information
- Device Name
- MAPERSOL
- K Number
- K080432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Preservation Solutions, Inc.
- Date Received
- February 19, 2008
- Decision Date
- August 8, 2008
- Product Code
- KDN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Preservation Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151728 | CoStorSol plus G | Sep 18, 2015 | Substantially Equivalent |
| K091245 | COSTORSOL | Jun 17, 2009 | Substantially Equivalent |
| K083453 | COSTORSOL | Jan 21, 2009 | Substantially Equivalent |
| K073693 | COSTORSOL | Jul 3, 2008 | Substantially Equivalent |
| K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 | Oct 9, 2002 | Substantially Equivalent |