FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GUTTA GUN
K Number: K771406
·
Decision Aug 26, 1977
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
15
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- GUTTA GUN
- K Number
- K771406
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Aus-Tex Dental Mfg. & Design
- Date Received
- July 29, 1977
- Decision Date
- August 26, 1977
- Product Code
- EIC
- 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 |
|---|---|---|---|
| EIC | Syringe, Periodontic, Endodontic, Irrigating | FDA class 1 | Dental |
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