FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
K Number: K860552
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
2
Review Days
62
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Basic Information
- Device Name
- PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
- K Number
- K860552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Laurie Ann Kaiser, Ph.D.
- Date Received
- February 14, 1986
- Decision Date
- April 17, 1986
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Laurie Ann Kaiser, Ph.D.
| K Number | Device Name | ||
|---|---|---|---|
| K800191 | PERITONE | Apr 16, 1980 | Substantially Equivalent |