FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUN MEDICAL LAMINARIA CERVICAL DILATOR
K Number: K845006
·
Decision May 1, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
4
Review Days
126
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Basic Information
- Device Name
- SUN MEDICAL LAMINARIA CERVICAL DILATOR
- K Number
- K845006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Sun Medical, Inc.
- Date Received
- December 26, 1984
- Decision Date
- May 1, 1985
- 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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