FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VAGINAL ILLUMINATOR, MODEL 78570
K Number: K771181
·
Decision Jul 14, 1977
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
1
Applicant Total
104
Review Days
14
Basic Information
- Device Name
- VAGINAL ILLUMINATOR, MODEL 78570
- K Number
- K771181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- WELCH ALLYN, INC.
- Date Received
- June 30, 1977
- Decision Date
- July 14, 1977
- Product Code
- HDG
- 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 |
|---|---|---|---|
| HDG | Speculum, Vaginal, Metal, Fiberoptic | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDG), ordered by most recent decision date.
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