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510(k) K932731

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN by Johnson & Johnson Medical, Inc. — Product Code FYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1994
Date Received
June 7, 1993
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

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  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)

Other clearances for product code FYE

  • K912790 — SURGICAL GOWN (September 19, 1991)
  • 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)