FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSE LAVAGE
K Number: K854543
·
Decision Jan 27, 1986
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
7
Review Days
75
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Basic Information
- Device Name
- PULSE LAVAGE
- K Number
- K854543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tava Surgical Instruments
- Date Received
- November 13, 1985
- Decision Date
- January 27, 1986
- Product Code
- FQH
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
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Other Clearances by Tava Surgical Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K935367 | TAVA WIRE-DRIVER | Apr 21, 1994 | Substantially Equivalent |
| K940109 | TAVA K-WIRE | Feb 22, 1994 | Substantially Equivalent |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | Jan 30, 1989 | Substantially Equivalent |
| K884492 | MICRO SURGICAL INSTRUMENT SYSTEM | Nov 16, 1988 | Substantially Equivalent |
| K872475 | SURGICAL BUR | Jul 2, 1987 | Substantially Equivalent |
| K863788 | SAWBLADE | Oct 14, 1986 | Substantially Equivalent |