FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL LIGHT HANDLE COVER
K Number: K133554
·
Decision Apr 8, 2014
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
25
Applicant Total
1
Review Days
140
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Basic Information
- Device Name
- SURGICAL LIGHT HANDLE COVER
- K Number
- K133554
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microtek Medical, Inc. an Ecolab Company
- Date Received
- November 19, 2013
- Decision Date
- April 8, 2014
- Product Code
- FTA
- 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 |
|---|---|---|---|
| FTA | Light, Surgical, Accessories | FDA class 2 | General, Plastic Surgery |
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