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510(k) K923188

DYNASTY IMPERVIOUS ISOLATION J-SUIT by Dynatech Medical Products — Product Code FYC

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

Other clearances by Dynatech Medical Products

  • K923187 — IMPERVIOUS ISOLATION SHOE COVERS (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)

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  • K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (January 4, 2023)
  • K212717 — Paneffort AAMI Level 3 Isolation Gown (November 30, 2022)
  • K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable G (October 21, 2022)
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  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (August 12, 2022)
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