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510(k) K071775

DASH by Ezsurgical — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2007
Date Received
June 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
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  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
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