FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRE-DENT SYSTEM
K Number: K800736
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
5
Applicant Total
3
Review Days
22
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Basic Information
- Device Name
- PRE-DENT SYSTEM
- K Number
- K800736
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9050
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Pre-Dent System
- Date Received
- April 2, 1980
- Decision Date
- April 24, 1980
- Product Code
- KSS
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KSS | Supplies, Blood-Bank | FDA class 1 | Hematology |
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