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510(k) K031408

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) by Deroyal — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2003
Date Received
May 5, 2003
Clearance Type
Traditional
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

Other clearances by Deroyal

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  • K033057 — DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE (November 20, 2003)
  • K030908 — DEROYAL SURGICAL DRAPES BACKTABLE COVER (August 11, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)

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