FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE UNIVERSAL TONG
K Number: K842680
·
Decision Sep 4, 1984
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
111
Review Days
56
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Basic Information
- Device Name
- ACE UNIVERSAL TONG
- K Number
- K842680
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5960
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Buckman Co., Inc.
- Date Received
- July 10, 1984
- Decision Date
- September 4, 1984
- Product Code
- HAX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAX | Tong, Skull For Traction | FDA class 2 | Neurology |
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|---|---|---|---|
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| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
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| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |