FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CIN-SHEAR
K Number: K840352
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
2
Review Days
70
Basic Information
- Device Name
- CIN-SHEAR
- K Number
- K840352
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- ROLAND J. ZWICK, INC.
- Date Received
- January 26, 1984
- Decision Date
- April 5, 1984
- Product Code
- HFB
- 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 |
|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | FDA class 1 | Obstetrics/Gynecology |
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Other Clearances by ROLAND J. ZWICK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K860796 | DISPO-URETTE | Apr 8, 1986 | Substantially Equivalent |