FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SUPPORT ARM
K Number: K864117
·
Decision Nov 3, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
13
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Basic Information
- Device Name
- SUPPORT ARM
- K Number
- K864117
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Leonard Medical, Inc.
- Date Received
- October 21, 1986
- Decision Date
- November 3, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
Other Clearances by Leonard Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951854 | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY | Jun 21, 1995 | Substantially Equivalent |
| K903536 | SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) | Sep 6, 1990 | Substantially Equivalent |
| K895685 | SMALL JOINT HAND INSTRUMENTS | Oct 16, 1989 | Substantially Equivalent |
| K884308 | MANDIBLE MANIPULATOR | Mar 31, 1989 | Substantially Equivalent |
| K884314 | LEONARD MEDICAL 1.7MM ARTHROSCOPE | Mar 13, 1989 | Substantially Equivalent |
| K873139 | VARUS AND VALGUS LEG HOLDER | Sep 16, 1987 | Substantially Equivalent |