FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K Number: K964114
·
Decision May 6, 1997
Classifications
1
FEI Numbers
329
Registration Numbers
329
Same Product Code
598
Applicant Total
303
Review Days
203
Basic Information
- Device Name
- DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
- K Number
- K964114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY, INC.
- Date Received
- October 15, 1996
- Decision Date
- May 6, 1997
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
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