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510(k) K971702

FAR-EAST BARRIER GOWNS by Far East Science & Technology Development Co., Ltd. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1997
Date Received
May 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Far East Science & Technology Development Co., Ltd.

  • K970988 — FAR-EAST BOUFFANT CAPS (July 10, 1997)
  • K971191 — FAR-EAST SHOE COVERS (July 10, 1997)

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