FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RACESTYPTINE CORD
K Number: K760657
·
Decision Sep 27, 1976
Classifications
1
FEI Numbers
327
Registration Numbers
327
Same Product Code
7
Applicant Total
11
Review Days
12
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Basic Information
- Device Name
- RACESTYPTINE CORD
- K Number
- K760657
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Septodont, Inc.
- Date Received
- September 15, 1976
- Decision Date
- September 27, 1976
- Product Code
- EIG
- 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 |
|---|---|---|---|
| EIG | Retractor, All Types | FDA class 1 | Dental |
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Other Clearances by Septodont, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780003 | ENDOSOLV E | Jan 20, 1978 | Substantially Equivalent |
| K771114 | NEUTROCIM | Jan 4, 1978 | Substantially Equivalent |
| K761355 | SELFAST | Jan 3, 1977 | Substantially Equivalent |
| K761354 | CIMPAT (PINK AND WHITE) | Jan 3, 1977 | Substantially Equivalent |
| K760798 | FLUOCAL GEL MINT | Nov 24, 1976 | Substantially Equivalent |
| K760799 | FLUOCAL GEL ORANGE | Nov 24, 1976 | Substantially Equivalent |
| K761024 | RACESTYPTINE RINGS | Nov 19, 1976 | Substantially Equivalent |
| K760658 | DETARTRINE P | Sep 27, 1976 | Substantially Equivalent |
| K760659 | CALCIPULPE | Sep 27, 1976 | Substantially Equivalent |
| K760660 | HYDROL | Sep 27, 1976 | Substantially Equivalent |