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510(k) K092086

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 by Amerx Health Care Corp. — Product Code SEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
July 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressings Containing Topical Analgesics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.

Other clearances by Amerx Health Care Corp.

  • K971918 — AMERIGEL OINTMENT SATURATED WOUND DRESSING (August 12, 1997)
  • K970133 — AMERIGEL OINTMENT (April 14, 1997)

Other clearances for product code SEJ

  • K053476 — ALLWOUND (June 26, 2006)
  • K020540 — REGENECARE WOUND GEL (November 1, 2002)
  • K001023 — FREEDOM, MODEL 4660 (September 22, 2000)
  • K922636 — HEMO-STAT (November 9, 1992)
  • K912565 — MICRO-COLL COLLAGEN WOUND SPRAY (June 11, 1992)