FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZ-CIRC
K Number: K963223
·
Decision Apr 23, 1997
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
35
Applicant Total
1
Review Days
250
Basic Information
- Device Name
- EZ-CIRC
- K Number
- K963223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHYLLIS ADAMS, RN, NPC, MSN
- Date Received
- August 16, 1996
- Decision Date
- April 23, 1997
- Product Code
- HFW
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
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