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510(k) K912790

SURGICAL GOWN by Unicor Federal Dept. of Justice — Product Code FYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1991
Date Received
June 25, 1991
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 for product code FYE

  • K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN (April 11, 1994)
  • K910920 — PROTEKT GLOVES (May 15, 1991)
  • K910941 — LIFELINER SURGICAL GLOVE (May 9, 1991)
  • K895667 — STERILE SURGICAL GOWN (October 13, 1989)
  • K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS (September 19, 1989)
  • K894760 — CLOTHINGUARD (August 18, 1989)