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510(k) K803171

PROCEDURE & RECOVERY PATIENT SUIT by Alba Health Care — Product Code FYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1981
Date Received
December 15, 1980
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 Alba Health Care

  • K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIP (January 20, 1987)
  • K861154 — ALBA HEALTH CARE PLAIN PACKING STRIP (April 15, 1986)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K850881 — ALBA DRY BURN PAD (April 17, 1985)
  • K850904 — ALBA DRY BURN DRESSING (April 17, 1985)
  • K850241 — ALBA HEALTH CARE NON-ADHERING DRESSING (March 12, 1985)
  • K812904 — STERILE ORTHOPEDIC STOCKINETTE (January 18, 1982)

Other clearances for product code FYB

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K891820 — DISPOSABLE MEDICAL GOWNS (July 24, 1989)
  • K891053 — DENTAL BIB (April 12, 1989)
  • K801570 — SHIELD DISP. PATIENTS PONCHO GOWNS (July 28, 1980)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)