FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
K Number: K083355
·
Decision Dec 29, 2008
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
- K Number
- K083355
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blairex Laboratories, Inc.
- Date Received
- November 13, 2008
- Decision Date
- December 29, 2008
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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