FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCURETTE
K Number: K820641
·
Decision Jun 22, 1982
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
4
Applicant Total
5
Review Days
106
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Basic Information
- Device Name
- ACCURETTE
- K Number
- K820641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1060
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Axcan Scientific Corp.
- Date Received
- March 8, 1982
- Decision Date
- June 22, 1982
- Product Code
- HFF
- 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 |
|---|---|---|---|
| HFF | Aspirator, Endometrial | FDA class 2 | Obstetrics/Gynecology |
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