FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I
K Number: K093729
·
Decision Jun 8, 2010
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
3
Review Days
187
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Basic Information
- Device Name
- GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I
- K Number
- K093729
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hemcon Medical Technologies Europe, Ltd.
- Date Received
- December 3, 2009
- Decision Date
- June 8, 2010
- Product Code
- QSY
- 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 |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
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