FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELF RETAINING SOFT TISSUE RETRACTOR
K Number: K101609
·
Decision Dec 9, 2010
Classifications
1
FEI Numbers
1140
Registration Numbers
1140
Same Product Code
57
Applicant Total
4
Review Days
184
Basic Information
- Device Name
- SELF RETAINING SOFT TISSUE RETRACTOR
- K Number
- K101609
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- KOROS USA, INC.
- Date Received
- June 8, 2010
- Decision Date
- December 9, 2010
- Product Code
- LXH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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