FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOOTH PRESERVING SYSTEM
K Number: K875221
·
Decision Apr 14, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
3
Applicant Total
1
Review Days
114
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Basic Information
- Device Name
- TOOTH PRESERVING SYSTEM
- K Number
- K875221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biological Rescue Products, Inc.
- Date Received
- December 22, 1987
- Decision Date
- April 14, 1988
- Product Code
- KJF
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KJF | System, Suspension, Cell Culture | FDA class 1 | Hematology |
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