Product code SEJ

Device name: Wound Dressings Containing Topical Analgesics
Medical specialty: Unknown
Device class: U
Review panel: SU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K092086	AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027	Amerx Health Care Corp.	2009-07-30
K053476	ALLWOUND	At Squared, LLC	2006-06-26
K020540	REGENECARE WOUND GEL	Mpm Medical., Inc.	2002-11-01
K001023	FREEDOM, MODEL 4660	Johnson & Johnson Consumer Companies, Inc.	2000-09-22
K922636	HEMO-STAT	Mckinley-Ross Laboratories, Inc.	1992-11-09
K912565	MICRO-COLL COLLAGEN WOUND SPRAY	Micro-Coll	1992-06-11

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