FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLINE CIRCUMCISION TRAY
K Number: K970282
·
Decision Mar 6, 1997
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
11
Review Days
41
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Basic Information
- Device Name
- MEDLINE CIRCUMCISION TRAY
- K Number
- K970282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline
- Date Received
- January 24, 1997
- Decision Date
- March 6, 1997
- Product Code
- HFX
- 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 |
|---|---|---|---|
| HFX | Clamp, Circumcision | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFX), ordered by most recent decision date.
Konig Bell Circumcision Clamp
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Circumplast Circumcision Device
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MALE CIRCUMCISION KITS:RAPIDECLAMP
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SHANGRING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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