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510(k) K923187

IMPERVIOUS ISOLATION SHOE COVERS by Dynatech Medical Products — Product Code FXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1993
Date Received
June 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoes, Operating-Room
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
Submission Type

Other clearances by Dynatech Medical Products

  • K923188 — DYNASTY IMPERVIOUS ISOLATION J-SUIT (January 29, 1993)
  • K922234 — DYNASTY ISOLATION GOWN (August 11, 1992)
  • K893520 — DR. BOO LATEX EXAMINATION GLOVES (August 21, 1989)
  • K770730 — PUMP, INFUSION, DYNATECH/HANDLEY (July 11, 1977)