FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOCYTE TM
K Number: K944238
·
Decision Sep 15, 1995
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
10
Applicant Total
4
Review Days
380
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Basic Information
- Device Name
- ENDOCYTE TM
- K Number
- K944238
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- D.L. Nelson and Assoc., Inc.
- Date Received
- August 31, 1994
- Decision Date
- September 15, 1995
- Product Code
- HCY
- 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 |
|---|---|---|---|
| HCY | Curette, Uterine | FDA class 1 | Obstetrics/Gynecology |
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