FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K Number: K926247
·
Decision Apr 14, 1993
Classifications
1
FEI Numbers
343
Registration Numbers
344
Same Product Code
53
Applicant Total
68
Review Days
121
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Basic Information
- Device Name
- OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
- K Number
- K926247
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6865
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Omron Healthcare, Inc.
- Date Received
- December 14, 1992
- Decision Date
- April 14, 1993
- Product Code
- JEQ
- 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 |
|---|---|---|---|
| JEQ | Toothbrush, Powered | FDA class 1 | Dental |
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