FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARALLELING GUIDES
K Number: K914715
·
Decision Feb 16, 1994
Classifications
1
FEI Numbers
526
Registration Numbers
526
Same Product Code
18
Applicant Total
3
Review Days
852
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Basic Information
- Device Name
- PARALLELING GUIDES
- K Number
- K914715
- 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
- Implant Corp. of America
- Date Received
- October 18, 1991
- Decision Date
- February 16, 1994
- Product Code
- FZX
- 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 |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
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