FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEW LENGTH SUGITA APPLIERS
K Number: K902516
·
Decision Jul 3, 1990
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
3
Review Days
26
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Basic Information
- Device Name
- NEW LENGTH SUGITA APPLIERS
- K Number
- K902516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Sims Surgical, Inc.
- Date Received
- June 7, 1990
- Decision Date
- July 3, 1990
- Product Code
- HIC
- 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 |
|---|---|---|---|
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | FDA class 2 | Obstetrics/Gynecology |
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