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510(k) K130693

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM by Aseptico, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2013
Date Received
March 14, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by Aseptico, Inc.

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  • K051077 — E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 (May 3, 2005)
  • K050201 — AEU-14CF EXPENDITION (March 18, 2005)
  • K030895 — ASEPTICO ENDOPEX V, MODEL AEU-40 (December 3, 2003)
  • K030163 — ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (March 3, 2003)

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