FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
K Number: K040936
·
Decision May 3, 2004
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
1
Review Days
24
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Basic Information
- Device Name
- PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
- K Number
- K040936
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leda Co., Ltd.
- Date Received
- April 9, 2004
- Decision Date
- May 3, 2004
- Product Code
- FQM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQM | Bandage, Elastic | FDA class 1 | General Hospital |
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