FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILTER SYSTEM, ALTNER DISPOSABLE
K Number: K790209
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
26
Applicant Total
45
Review Days
27
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Basic Information
- Device Name
- FILTER SYSTEM, ALTNER DISPOSABLE
- K Number
- K790209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Equipment Co., Inc.
- Date Received
- January 30, 1979
- Decision Date
- February 26, 1979
- Product Code
- GAZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GAZ | Tubing, Noninvasive | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAZ), ordered by most recent decision date.
SUCTION/IRRIGATOR TUBING KIT
FDA 510(k)
FDA Class 2
·General Hospital
TUBING, NONINVASIVE
FDA 510(k)
FDA Class 2
·General Hospital
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
FDA 510(k)
FDA Class 2
·General Hospital
NORTEC CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION SET W/Y CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Orthopedic Equipment Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834035 | UNIVERSAL SELF-ALIGNING ACETABULAR COM | Jun 19, 1984 | Substantially Equivalent |
| K841189 | OEC/REZAIAN SPINAL FIXATOR | May 16, 1984 | Substantially Equivalent |
| K800530 | SCHLEIN TRI-SURFACE ANKLE | Apr 2, 1980 | Substantially Equivalent |
| K781445 | SPREADER | Sep 27, 1979 | Substantially Equivalent |
| K790247 | TOURNIQUET TEST GAGE | Feb 26, 1979 | Substantially Equivalent |
| K781450 | DRIVERS | Sep 27, 1978 | Substantially Equivalent |
| K781444 | OUTRIGGER DISTRACTION UNIT | Sep 27, 1978 | Substantially Equivalent |
| K781451 | FLAT WRENCH | Sep 27, 1978 | Substantially Equivalent |
| K781447 | THREADED ROD CLAMP | Sep 27, 1978 | Substantially Equivalent |
| K781449 | HARRINGTON SPINAL ELEVATOR | Sep 27, 1978 | Substantially Equivalent |