FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MVS UNIT, MODEL SEU-8 AND DEU-8, 80
K Number: K782068
·
Decision Jan 26, 1979
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
16
Applicant Total
279
Review Days
44
Basic Information
- Device Name
- MVS UNIT, MODEL SEU-8 AND DEU-8, 80
- K Number
- K782068
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- DENTSPLY INTL.
- Date Received
- December 13, 1978
- Decision Date
- January 26, 1979
- Product Code
- EHZ
- 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 |
|---|---|---|---|
| EHZ | Evacuator, Oral Cavity | FDA class 1 | Dental |
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