FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ASEPTICO ENDOPEX V, MODEL AEU-40
K Number: K030895
·
Decision Dec 3, 2003
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
44
Applicant Total
17
Review Days
257
Basic Information
- Device Name
- ASEPTICO ENDOPEX V, MODEL AEU-40
- K Number
- K030895
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ASEPTICO, INC.
- Date Received
- March 21, 2003
- Decision Date
- December 3, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQY), ordered by most recent decision date.
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Electronic Apex Locator (Alpha Apex I)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
FDA 510(k)
FDA Unclassified
·Unknown
Root Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
EQ-PEX
FDA 510(k)
FDA Unclassified
·Unknown
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| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | May 3, 2005 | Substantially Equivalent |
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| K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Mar 3, 2003 | Substantially Equivalent |
| K022217 | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM | Oct 24, 2002 | Substantially Equivalent |