FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
APEX LOCATOR BINGO-1020
K Number: K992233
·
Decision Nov 30, 1999
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
3
Review Days
158
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Basic Information
- Device Name
- APEX LOCATOR BINGO-1020
- K Number
- K992233
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dent Corp. Research & Development
- Date Received
- June 25, 1999
- Decision Date
- November 30, 1999
- Product Code
- LQY
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LQY | Locator, Root Apex | FDA unclassified | Unknown |
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