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510(k) K945371

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS by Standard Textile Co., Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1995
Date Received
November 2, 1994
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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  • K041540 — COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (May 5, 2005)
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  • 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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