FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAMELBACK HANDLE-K841969-LABELING
K Number: K841970
·
Decision Jun 19, 1984
Classifications
1
FEI Numbers
1140
Registration Numbers
1140
Same Product Code
57
Applicant Total
19
Review Days
36
Basic Information
- Device Name
- CAMELBACK HANDLE-K841969-LABELING
- K Number
- K841970
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- STAINLESS MFG., INC.
- Date Received
- May 14, 1984
- Decision Date
- June 19, 1984
- Product Code
- LXH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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Other Clearances by STAINLESS MFG., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K841980 | SIDE CUTTING SERRATED BLADE | Aug 15, 1984 | Substantially Equivalent |
| K841969 | 6.5MM HEX HANDLE | Jun 19, 1984 | Substantially Equivalent |
| K841975 | ROSETTE KNIFE 4MM | Jun 19, 1984 | Substantially Equivalent |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Jun 19, 1984 | Substantially Equivalent |
| K841976 | HOOK KNIFE 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent |
| K841979 | 4MM CUP CURRETTE | Jun 19, 1984 | Substantially Equivalent |
| K841982 | MENISCOTOME 4MM & 5MM | Jun 19, 1984 | Substantially Equivalent |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | Jun 19, 1984 | Substantially Equivalent |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | Jun 19, 1984 | Substantially Equivalent |
| K841981 | 4MM & 5MM FILE | Jun 19, 1984 | Substantially Equivalent |