FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILASTIC BRAND G7-2090A
K Number: K760700
·
Decision Nov 2, 1976
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
95
Applicant Total
31
Review Days
41
Basic Information
- Device Name
- SILASTIC BRAND G7-2090A
- K Number
- K760700
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
- Date Received
- September 22, 1976
- Decision Date
- November 2, 1976
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
| K Number | Device Name | ||
|---|---|---|---|
| K853186 | SILASTIC INFLATABLE BONE PLUG H.P. | Sep 24, 1985 | Substantially Equivalent |
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| K850255 | DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET | May 1, 1985 | Substantially Equivalent |
| K843995 | TF-II HIP PROSTHESIS | Apr 23, 1985 | Substantially Equivalent |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | Dec 20, 1984 | Substantially Equivalent |
| K840357 | SSA HIP PROSTHESIS | Feb 17, 1984 | Substantially Equivalent |
| K831479 | METAL-BACKED ACETABULAR CUP | Jun 15, 1983 | Substantially Equivalent |
| K812864 | SILASTIC VOICE PROSTHESIS | Nov 24, 1981 | Substantially Equivalent |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Aug 18, 1981 | Substantially Equivalent |
| K811679 | SILASTIC TENDON PASSER H.P. | Jul 10, 1981 | Substantially Equivalent |