FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COVERSLIPPER
K Number: K780261
·
Decision Apr 18, 1978
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
0
Applicant Total
5
Review Days
61
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Basic Information
- Device Name
- COVERSLIPPER
- K Number
- K780261
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3400
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Shandon, Inc.
- Date Received
- February 16, 1978
- Decision Date
- April 18, 1978
- Product Code
- KIM
- 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 |
|---|---|---|---|
| KIM | Device For Sealing Microsections | FDA class 1 | Pathology |