FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXAKT CUTTING & GRINDING SYSTEM
K Number: K883514
·
Decision Aug 29, 1988
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
0
Applicant Total
1
Review Days
12
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Basic Information
- Device Name
- EXAKT CUTTING & GRINDING SYSTEM
- K Number
- K883514
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Exakt Medical Instruments, Inc.
- Date Received
- August 17, 1988
- Decision Date
- August 29, 1988
- Product Code
- IDP
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| IDP | Microtome, Cryostat | FDA class 1 | Pathology |