FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAMINARIA TENT
K Number: K892220
·
Decision Jun 14, 1989
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
5
Review Days
72
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Basic Information
- Device Name
- LAMINARIA TENT
- K Number
- K892220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Berkeley Medevices
- Date Received
- April 3, 1989
- Decision Date
- June 14, 1989
- Product Code
- HDY
- 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 |
|---|---|---|---|
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | FDA class 2 | Obstetrics/Gynecology |
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