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510(k) K922234

DYNASTY ISOLATION GOWN by Dynatech Medical Products — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1992
Date Received
May 13, 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)
  • K923188 — DYNASTY IMPERVIOUS ISOLATION J-SUIT (January 29, 1993)
  • K893520 — DR. BOO LATEX EXAMINATION GLOVES (August 21, 1989)
  • K770730 — PUMP, INFUSION, DYNATECH/HANDLEY (July 11, 1977)

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  • K223467 — Disposable Isolation Gown (February 10, 2023)
  • K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (February 8, 2023)
  • 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)
  • K214116 — AAMI4 Isolation Gown (October 11, 2022)
  • K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (August 12, 2022)
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