FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PERCLOT TOPICAL
K Number: K132105
·
Decision Apr 3, 2014
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
12
Review Days
269
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Basic Information
- Device Name
- PERCLOT TOPICAL
- K Number
- K132105
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cryolife, Inc.
- Date Received
- July 8, 2013
- Decision Date
- April 3, 2014
- 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 |
Similar 510(k) Clearances
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BloodSTOP iX Trauma Matrix (TM-iX-20)
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