FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
K Number: K910254
·
Decision Apr 18, 1991
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
15
Applicant Total
41
Review Days
86
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Basic Information
- Device Name
- DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
- K Number
- K910254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5400
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- CooperSurgical, Inc.
- Date Received
- January 22, 1991
- Decision Date
- April 18, 1991
- Product Code
- HHE
- 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 |
|---|---|---|---|
| HHE | Cup, Menstrual | FDA class 2 | Obstetrics/Gynecology |
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