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510(k) K891820

DISPOSABLE MEDICAL GOWNS by Bioshield, Inc. — Product Code FYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1989
Date Received
March 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code FYB

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K891053 — DENTAL BIB (April 12, 1989)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)
  • K801570 — SHIELD DISP. PATIENTS PONCHO GOWNS (July 28, 1980)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)