FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
K Number: K892882
·
Decision Jun 23, 1989
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
16
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
- K Number
- K892882
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Nieusma R & D, Inc.
- Date Received
- April 6, 1989
- Decision Date
- June 23, 1989
- 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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