FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARBON LIGHTS HAND SURGERY TABLE
K Number: K944779
·
Decision Oct 14, 1994
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
5
Review Days
17
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Basic Information
- Device Name
- CARBON LIGHTS HAND SURGERY TABLE
- K Number
- K944779
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Allen Medical Systems, Inc.
- Date Received
- September 27, 1994
- Decision Date
- October 14, 1994
- Product Code
- FWZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Allen Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971988 | ALLEN, ULTRA AND SMART SOCKETS | Jul 11, 1997 | Substantially Equivalent |
| K964273 | DURA-BOARD ARMBOARD | Jan 8, 1997 | Substantially Equivalent |
| K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER | Mar 12, 1996 | Substantially Equivalent |
| K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 | Apr 21, 1993 | Substantially Equivalent |