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510(k) K895667

STERILE SURGICAL GOWN by Clinitech, Inc. — Product Code FYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
September 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dress, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
Submission Type

Other clearances by Clinitech, Inc.

  • K896367 — STERILE SURGICAL DRAPES AND SHEETS (December 4, 1989)
  • K864311 — STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) (November 26, 1986)

Other clearances for product code FYE

  • K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN (April 11, 1994)
  • K912790 — SURGICAL GOWN (September 19, 1991)
  • K910920 — PROTEKT GLOVES (May 15, 1991)
  • K910941 — LIFELINER SURGICAL GLOVE (May 9, 1991)
  • K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS (September 19, 1989)
  • K894760 — CLOTHINGUARD (August 18, 1989)