FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
K Number: K011514
·
Decision Aug 13, 2001
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
- K Number
- K011514
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kencap , Ltd.
- Date Received
- May 17, 2001
- Decision Date
- August 13, 2001
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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