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510(k) K041653

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS by Standard Textile Co., Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2005
Date Received
June 17, 2004
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

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  • K060181 — COMPE1 1 -PLY SURGICAL GOWNS (March 7, 2006)
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  • K012268 — TRIMAX (December 3, 2001)
  • K012807 — MODIFICATION TO: COMPEL SURGICAL DRAPES (October 11, 2001)
  • K010799 — COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (June 7, 2001)

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