FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRI NEURO DRAPE
K Number: K091343
·
Decision Sep 22, 2009
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
4
Review Days
139
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Basic Information
- Device Name
- MRI NEURO DRAPE
- K Number
- K091343
- 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
- Surgivision, Inc.
- Date Received
- May 6, 2009
- Decision Date
- September 22, 2009
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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