FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUBRICANO-ULTRASOUND
K Number: K083358
·
Decision Jan 9, 2009
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
2
Review Days
87
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Basic Information
- Device Name
- LUBRICANO-ULTRASOUND
- K Number
- K083358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Farco Pharma GmbH
- Date Received
- October 14, 2008
- Decision Date
- January 9, 2009
- Product Code
- MUI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
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Other Clearances by Farco Pharma GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K081990 | LUBRICANO STERILE GEL | Dec 5, 2008 | Substantially Equivalent |