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510(k) K060181

COMPE1 1 -PLY SURGICAL GOWNS by Standard Textile Co., Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2006
Date Received
January 23, 2006
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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  • K041653 — COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS (July 1, 2005)
  • K041540 — COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (May 5, 2005)
  • K041539 — COMPEL SURGICAL GOWNS (April 28, 2005)
  • K041541 — COMPEL MLR SURGICAL GOWNS (March 16, 2005)
  • 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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  • K241214 — ProPel SG3™ Surgical Gown (September 10, 2024)
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  • K233068 — Disposable Surgical Gown (March 29, 2024)