FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL HEAD SUPPORT
K Number: K861915
·
Decision May 30, 1986
Classifications
1
FEI Numbers
279
Registration Numbers
280
Same Product Code
7
Applicant Total
80
Review Days
11
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Basic Information
- Device Name
- SURGICAL HEAD SUPPORT
- K Number
- K861915
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6820
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Treace Medical, Inc.
- Date Received
- May 19, 1986
- Decision Date
- May 30, 1986
- Product Code
- CCX
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCX | Support, Patient Position | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872000 | EYE GARD | Jul 21, 1987 | Substantially Equivalent |
| K870765 | CANNULATED INSTRUMENT CLEANERS | May 27, 1987 | Substantially Equivalent |
| K871706 | OPTHA PREP | May 18, 1987 | Substantially Equivalent |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | May 7, 1987 | Substantially Equivalent |
| K870766 | PROSTHESIS WIRE | Apr 15, 1987 | Substantially Equivalent |
| K870760 | BUR BRUSH | Mar 18, 1987 | Substantially Equivalent |