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510(k) K852091

ALBA DRY BURN PAD by Alba-Waldensian, Inc. — Product Code NAD

K852091 is an FDA 510(k) premarket notification submitted by Alba-Waldensian, Inc. for the device "ALBA DRY BURN PAD". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Alba-Waldensian, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1985
Date Received
May 13, 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-Waldensian, Inc.

  • K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (April 3, 2002)
  • K961405 — ALBA HEALTH PAS WRAP SYSTEM (December 26, 1996)
  • K792357 — STERILE IMPERVIOUS ORTHOPEDIC STOCKIN (December 18, 1979)
  • K781964 — COMPRESSION DEVICES, LIMB (December 12, 1978)
  • K780570 — TUBULAR DRESSING RETAINER (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K771913 — HEEL/ELBOW PROTECTOR (November 15, 1977)

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