Who is the manufacturer of DUKAL NON ADHERENT DRESSING?

Dukal Corp. filed the 510(k) submission for DUKAL NON ADHERENT DRESSING (K970455).

What is the FDA product code for DUKAL NON ADHERENT DRESSING?

EFQ. as a Class U device in the SU panel.

What is the regulatory pathway for DUKAL NON ADHERENT DRESSING?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DUKAL NON ADHERENT DRESSING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DUKAL NON ADHERENT DRESSING

K970455 · Dukal Corp. · EFQ · May 8, 1997 · SU

Device Facts

Record ID	K970455
Device Name	DUKAL NON ADHERENT DRESSING
Applicant	Dukal Corp.
Product Code	EFQ · SU
Decision Date	May 8, 1997
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.

Device Story

Dukal Non Adherent Pad; topical wound dressing; provides wound coverage and absorbency; used in clinical or home settings; applied by healthcare providers or patients; physical barrier function; prevents adherence to wound bed.

Clinical Evidence

Bench testing only; physical property comparison provided.

Technological Characteristics

Non-adherent pad; thickness 47 mil; Delnet fracture 5lb/in; T-Peel 700 lb/in; absorptive capacity 38 oz/yd²; MD tensile 6lb/in; basis weight 5.0 oz/yd².

Indications for Use

Indicated for use as a topical dressing to cover wounds or operative sites requiring absorbency.

Predicate Devices

Kendell Non Adherent Dressing

Related Devices

K970457 — DUKAL ABD COMBINE PAD · Dukal Corp. · May 8, 1997
K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING · Bioderm, Inc. · May 18, 1999
K965005 — IAMIN IMPREGNATED GAUZE DRESSING · Procyte Corp. · Feb 24, 1997
K980720 — NONWOVEN PAD · Convatec, A Division of E.R. Squibb & Sons · Apr 15, 1998
K983554 — ALLDRESS, ABSORBENT FILM DRESSING · Molnlycke Health Care, Inc. · Nov 10, 1998

Submission Summary (Full Text)

{0} 4F-1997 15:26 RMS 813 942 3828 P.04 K970455 # 510(K) SUMMARY (as required by 807.92(c)) MAY - 8 1997 Submitter of 510(k): Regulatory & Marketing Services, Inc. (RMS) 40178 U.S. 19 North Tarpon Springs, FL 34689 Phone: 813-942-3908 Fax: 813-942-3828 Contact Person: Ed Ransom Date of Summary: February 3, 1997 Trade Name: Dukal Non Adherent Pad Classification Name: Dressing Predicate Device: Kendell Non Adherent Dressing Device Description/ Comparison: | Material | Dukal | Kendall | | --- | --- | --- | | Thickness | 47 mil | same | | Delnet Fracture | 5lb/in | same | | T-Peel | 700 lb/in | same | | Absorptive Capacity | 38 oz/yd² | same | | MD Tensile | 6lb/in | same | | Basis weight | 5.0 oz/yd² | same | | Intended Use | Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency. | same | Intended Use: Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.