FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REACH* TOOTHBRUSH
K Number: K834580
·
Decision Feb 10, 1984
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
206
Review Days
43
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Basic Information
- Device Name
- REACH* TOOTHBRUSH
- K Number
- K834580
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- December 29, 1983
- Decision Date
- February 10, 1984
- Product Code
- EFW
- 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 |
|---|---|---|---|
| EFW | Toothbrush, Manual | FDA class 1 | Dental |
Similar 510(k) Clearances
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ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
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MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
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