FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANVIL RETRACTOR
K Number: K830585
·
Decision May 27, 1983
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
6
Review Days
93
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Basic Information
- Device Name
- ANVIL RETRACTOR
- K Number
- K830585
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Twin City Surgical, Inc.
- Date Received
- February 23, 1983
- Decision Date
- May 27, 1983
- Product Code
- GAD
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Twin City Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870767 | THE (CROM) TESTER | Mar 17, 1987 | Substantially Equivalent |
| K861632 | SIMS CHAIR | May 27, 1986 | Substantially Equivalent |
| K820660 | A HOOK DRIVER | Mar 19, 1982 | Substantially Equivalent |
| K820659 | A CALIPER | Mar 19, 1982 | Substantially Equivalent |
| K813067 | SPINAL WRENCH | Nov 24, 1981 | Substantially Equivalent |