FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORCEPS, SURGICAL GYNECOLOGICAL
K Number: K944055
·
Decision Sep 20, 1994
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
23
Applicant Total
3
Review Days
32
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Basic Information
- Device Name
- FORCEPS, SURGICAL GYNECOLOGICAL
- K Number
- K944055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owens Precision Systems, Inc.
- Date Received
- August 19, 1994
- Decision Date
- September 20, 1994
- Product Code
- HCZ
- 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 |
|---|---|---|---|
| HCZ | Forceps, Surgical, Gynecological | FDA class 2 | Obstetrics/Gynecology |
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