FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
K Number: K061308
·
Decision Jun 5, 2006
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
3
Review Days
26
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Basic Information
- Device Name
- TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
- K Number
- K061308
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinal Health 200, Inc.
- Date Received
- May 10, 2006
- Decision Date
- June 5, 2006
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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