FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POCKETIP 4414
K Number: K834545
·
Decision Mar 30, 1984
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
3
Review Days
94
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Basic Information
- Device Name
- POCKETIP 4414
- K Number
- K834545
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Vipont Laboratories, Inc.
- Date Received
- December 27, 1983
- Decision Date
- March 30, 1984
- Product Code
- EFS
- 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 |
|---|---|---|---|
| EFS | Unit, Oral Irrigation | FDA class 1 | Dental |
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