FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONOMER EVACUATION SYSTEM
K Number: K780202
·
Decision Feb 21, 1978
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
7
Applicant Total
8
Review Days
14
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Basic Information
- Device Name
- MONOMER EVACUATION SYSTEM
- K Number
- K780202
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4220
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Medishield, Inc.
- Date Received
- February 7, 1978
- Decision Date
- February 21, 1978
- Product Code
- JDY
- 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 |
|---|---|---|---|
| JDY | Evacuator, Vapor, Cement Monomer | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDY), ordered by most recent decision date.
CONTAIN(TM) LASER PLUME FILTER
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FDA Class 1
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LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
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CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
FDA 510(k)
FDA Class 1
·Orthopedic
CEMENT FUME EVACUATOR TANK & FILTER
FDA 510(k)
FDA Class 1
·Orthopedic
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
FDA 510(k)
FDA Class 1
·Orthopedic
MASK, VAPOR, MONOMER
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Medishield, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K781103 | SPECTRASCAN | Sep 27, 1978 | Substantially Equivalent |
| K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE | May 3, 1978 | Substantially Equivalent |
| K780646 | AIR-PWOERED COLDRILL | Apr 28, 1978 | Substantially Equivalent |
| K770161 | MICROFENESTRATED HIP REPLACEMENT COMPON. | Jan 26, 1977 | Substantially Equivalent |
| K761020 | ANKLE (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K760668 | SELECTATEC SYSTEM | Sep 27, 1976 | Substantially Equivalent |