FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTHA PREP
K Number: K871706
·
Decision May 18, 1987
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
6
Applicant Total
80
Review Days
17
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Basic Information
- Device Name
- OPTHA PREP
- K Number
- K871706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Treace Medical, Inc.
- Date Received
- May 1, 1987
- Decision Date
- May 18, 1987
- Product Code
- HMT
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HMT | Drape, Patient, Ophthalmic | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Treace Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883727 | BUCKET PROSTHESIS PORP | Jan 13, 1989 | Substantially Equivalent |
| K882349 | MALLET, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K874779 | BIPOLATOR 50 | Jan 29, 1988 | Substantially Equivalent |
| 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 |
| 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 |
| K870763 | SUPER SCISSORS | Mar 18, 1987 | Substantially Equivalent |