FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RACESTYPTINE
K Number: K884653
·
Decision Jan 19, 1989
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
21
Review Days
73
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Basic Information
- Device Name
- RACESTYPTINE
- K Number
- K884653
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Specialites Septodont
- Date Received
- November 7, 1988
- Decision Date
- January 19, 1989
- Product Code
- EKJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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| K920692 | SEPTOCALCINE ULTRA | Apr 21, 1992 | Substantially Equivalent |
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| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Nov 7, 1991 | Substantially Equivalent |
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