FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRRIGATION SET
K Number: K883300
·
Decision Nov 1, 1988
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
2
Review Days
89
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Basic Information
- Device Name
- IRRIGATION SET
- K Number
- K883300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Edwards Orthopaedics Div., Baxter Healthcare Corp.
- Date Received
- August 4, 1988
- Decision Date
- November 1, 1988
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Edwards Orthopaedics Div., Baxter Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883299 | SUTURE RETENTION DEVICE | Aug 23, 1988 | Substantially Equivalent |