FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
K Number: K870915
·
Decision Apr 1, 1987
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
645
Review Days
26
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Basic Information
- Device Name
- SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
- K Number
- K870915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- March 6, 1987
- Decision Date
- April 1, 1987
- 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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