FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENTELLAN
K Number: K800847
·
Decision May 8, 1980
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
5
Review Days
23
Basic Information
- Device Name
- ENTELLAN
- K Number
- K800847
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- MCB MANUFACTURING CHEMISTS, INC.
- Date Received
- April 15, 1980
- Decision Date
- May 8, 1980
- Product Code
- KEP
- Advisory Committee
- Pathology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KEP | Media, Mounting, Oil Soluble | FDA class 1 | Pathology |
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