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510(k) K010799

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) by Standard Textile Co., Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2001
Date Received
March 16, 2001
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)
  • 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)

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