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510(k) K032757

A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE by A-Dec, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2003
Date Received
September 5, 2003
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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  • K070663 — A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H S (July 5, 2007)
  • K051657 — A-DEC SELF-CONTAINED WATER SYSTEM (August 30, 2005)
  • K032756 — A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (December 4, 2003)

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