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510(k) K050786

BARRIER SURGICAL GOWNS by Molnlycke Health Care — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2005
Date Received
March 28, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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  • K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPREN (October 5, 2006)
  • K051625 — BARRIER SURGICAL DRAPES (July 14, 2005)
  • K031131 — KLINIDRAPE SURGICAL DRAPES (June 10, 2003)

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