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510(k) K891053

DENTAL BIB by Dispomed, Inc. — Product Code FYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1989
Date Received
February 27, 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 by Dispomed, Inc.

  • K892748 — PATIENT EXAM GLOVES (MFG. AMMATEX) (August 10, 1989)
  • K891054 — NON-STERILE GAUZE SPONGE (May 1, 1989)
  • K891056 — SURGICAL CONE MASK (April 12, 1989)
  • K891051 — SURGICAL FACE MASK-EAR LOOP (April 12, 1989)
  • K891058 — DENTAL GOWN (April 12, 1989)
  • K891052 — SPLASH GUARD GOGGLE (April 12, 1989)

Other clearances for product code FYB

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K891820 — DISPOSABLE MEDICAL GOWNS (July 24, 1989)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)
  • K801570 — SHIELD DISP. PATIENTS PONCHO GOWNS (July 28, 1980)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)