FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VABRA ASPIRATOR
K Number: K800833
·
Decision May 14, 1980
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- VABRA ASPIRATOR
- K Number
- K800833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Cooper Medical Devices Corp.
- Date Received
- April 14, 1980
- Decision Date
- May 14, 1980
- Product Code
- HHI
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHI | System, Abortion, Vacuum | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHI), ordered by most recent decision date.
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BERKELEY V-10 VACUUM CURETTAGE SYSTEM
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CYTOPREP
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CYTOSMEAR BRUSH
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CANNULA, SUCTION UTERINE
FDA 510(k)
FDA Class 2
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Other Clearances by Cooper Medical Devices Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K802927 | SEBESTYEN IRRIGATING CONTACT LENS | Feb 5, 1981 | Substantially Equivalent |
| K802971 | LANDERS CONTACT LENS | Feb 5, 1981 | Substantially Equivalent |
| K801850 | CHARLES PNEUMATIC INTRAOCULAR SCISSORS | Sep 16, 1980 | Substantially Equivalent |
| K801411 | MAY ILLUMINATED/INFUSION PIC | Jul 21, 1980 | Substantially Equivalent |
| K801312 | THE PROTECTORS | Jun 17, 1980 | Substantially Equivalent |
| K791898 | OCUTOME MODEL 8000 | Oct 30, 1979 | Substantially Equivalent |