FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Standard Clamp
K Number: K153358
·
Decision May 2, 2016
Classifications
1
FEI Numbers
270
Registration Numbers
270
Same Product Code
31
Applicant Total
10
Review Days
164
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Basic Information
- Device Name
- Standard Clamp
- K Number
- K153358
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Standard Bariatrics
- Date Received
- November 20, 2015
- Decision Date
- May 2, 2016
- Product Code
- GDJ
- 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 |
|---|---|---|---|
| GDJ | Clamp, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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