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510(k) K850904

ALBA DRY BURN DRESSING by Alba Health Care — Product Code NAD

K850904 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "ALBA DRY BURN DRESSING". The FDA issued a decision of Substantially Equivalent on April 17, 1985. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Alba Health Care has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1985
Date Received
March 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
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)
  • K850241 — ALBA HEALTH CARE NON-ADHERING DRESSING (March 12, 1985)
  • K812904 — STERILE ORTHOPEDIC STOCKINETTE (January 18, 1982)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources