FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
K Number: K041080
·
Decision Nov 30, 2004
Classifications
1
FEI Numbers
165
Registration Numbers
165
Same Product Code
109
Applicant Total
1
Review Days
218
Basic Information
- Device Name
- SURGICAL DRAPE KIT - D.I.R.R.A. SRL
- K Number
- K041080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- D.I.R.R.A. S.R.L.
- Date Received
- April 26, 2004
- Decision Date
- November 30, 2004
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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