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510(k) K972410

IMPERVIOUS ISOLATION GOWN by Kentron Health Care, Inc. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
June 26, 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 Kentron Health Care, Inc.

  • K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM (August 27, 2003)
  • K971917 — KENTRON'S ISOLATION GOWN (September 19, 1997)
  • K953465 — KENTEMP (December 15, 1995)
  • K953914 — KENTEX (November 6, 1995)
  • K953830 — KENSORB (October 3, 1995)

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