FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE PLASTIC VAGINAL SPECULUM
K Number: K903080
·
Decision Sep 19, 1990
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
70
Applicant Total
1
Review Days
69
Basic Information
- Device Name
- DISPOSABLE PLASTIC VAGINAL SPECULUM
- K Number
- K903080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- DAWNEX INDUSTRIES, INC.
- Date Received
- July 12, 1990
- Decision Date
- September 19, 1990
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIB), ordered by most recent decision date.
BRELLA-SPEC(TM) VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IOB DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CLEARSPEC SINGLE USE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECULUM, VAGINAL, NONMETAL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOLPLUX SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NON-STERILE DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology