FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VARIODRAIN
K Number: K810636
·
Decision May 1, 1981
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
7
Review Days
52
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Basic Information
- Device Name
- VARIODRAIN
- K Number
- K810636
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Colmed, Ltd.
- Date Received
- March 10, 1981
- Decision Date
- May 1, 1981
- 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 Colmed, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K811209 | JACOB WIRZ TRANSFIXATION PIN | Jun 16, 1981 | Substantially Equivalent |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Feb 10, 1981 | Substantially Equivalent |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | May 28, 1980 | Substantially Equivalent |
| K801006 | CHARNLEY DESIGN HIP PROSTHESIS | May 20, 1980 | Substantially Equivalent |
| K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | May 14, 1980 | Substantially Equivalent |
| K792241 | PELIMIT | Nov 30, 1979 | Substantially Equivalent |