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510(k) K864311

STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) by Clinitech, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1986
Date Received
November 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Clinitech, Inc.

  • K896367 — STERILE SURGICAL DRAPES AND SHEETS (December 4, 1989)
  • K895667 — STERILE SURGICAL GOWN (October 13, 1989)

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