FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VAGI-SPEC
K Number: K790852
·
Decision Jul 30, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
57
Applicant Total
7
Review Days
87
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Basic Information
- Device Name
- VAGI-SPEC
- K Number
- K790852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- C. Intl.
- Date Received
- May 4, 1979
- Decision Date
- July 30, 1979
- Product Code
- KNA
- 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 |
|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNA), ordered by most recent decision date.
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COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
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BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
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EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
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Other Clearances by C. Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K792494 | CATHETERIZATION FORCEP | Dec 20, 1979 | Substantially Equivalent |
| K790855 | SURGICAL DRAPE CLIP #201 | Aug 3, 1979 | Substantially Equivalent |
| K790853 | EASY-SPEC | Jul 30, 1979 | Substantially Equivalent |
| K790851 | VAGI-PRESS #401 | Jul 30, 1979 | Substantially Equivalent |
| K790854 | FORCEPS #101 AND #102 | Jun 5, 1979 | Substantially Equivalent |
| K790856 | PROCTOSCOPE #501 | May 29, 1979 | Substantially Equivalent |