FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMO-BARRIER
K Number: K953500
·
Decision Jan 24, 1996
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
4
Review Days
182
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Basic Information
- Device Name
- HEMO-BARRIER
- K Number
- K953500
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asia Dynamics, Inc.
- Date Received
- July 26, 1995
- Decision Date
- January 24, 1996
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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