FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
K Number: K021258
·
Decision May 10, 2002
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
4
Applicant Total
1
Review Days
21
Basic Information
- Device Name
- GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
- K Number
- K021258
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GERM TERMINATOR CORPORATION
- Date Received
- April 19, 2002
- Decision Date
- May 10, 2002
- Product Code
- MCF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCF | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile | FDA class 1 | Dental |
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