FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
K Number: K905470
·
Decision Apr 25, 1991
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
32
Applicant Total
3
Review Days
140
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Basic Information
- Device Name
- STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
- K Number
- K905470
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6300
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Elastomade Accessories Sdn Bhd
- Date Received
- December 6, 1990
- Decision Date
- April 25, 1991
- Product Code
- EIE
- 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 |
|---|---|---|---|
| EIE | Dam, Rubber | FDA class 1 | Dental |
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