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510(k) K060076

SURGICOUNT SAFETY-SPONGE SYSTEM by Surgicount Medical — Product Code LWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2006
Date Received
January 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
Review Panel
SU
Submission Type

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  • K061316 — MEDLINE SURGICAL SPONGE SCANNER (November 2, 2006)
  • K982260 — MARKWELL GAUZE SPONGE (August 12, 1998)
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