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510(k) K051657

A-DEC SELF-CONTAINED WATER SYSTEM by A-Dec, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2005
Date Received
June 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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  • K032757 — A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE (December 10, 2003)
  • K032756 — A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (December 4, 2003)

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