Who is the manufacturer of DUKAL ABD COMBINE PAD?

Dukal Corp. filed the 510(k) submission for DUKAL ABD COMBINE PAD (K970457).

What is the FDA product code for DUKAL ABD COMBINE PAD?

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

What is the regulatory pathway for DUKAL ABD COMBINE PAD?

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

Who can help prepare an FDA 510(k) submission like DUKAL ABD COMBINE PAD?

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 ABD COMBINE PAD

K970457 · Dukal Corp. · EFQ · May 8, 1997 · SU

Device Facts

Record ID	K970457
Device Name	DUKAL ABD COMBINE PAD
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

The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.

Device Story

Dukal Sterile ABD Combine pad; topical wound dressing; provides absorbency for wounds or operative sites; used in clinical settings; applied by healthcare providers; protects wound site; manages exudate.

Clinical Evidence

bench testing only

Technological Characteristics

Absorbent 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

Hermitage Combine II Dressing

Related Devices

K970455 — DUKAL NON ADHERENT DRESSING · Dukal Corp. · May 8, 1997
K973511 — KENDALL CURITY PETROLATUM GAUZE · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 16, 1997
K980720 — NONWOVEN PAD · Convatec, A Division of E.R. Squibb & Sons · Apr 15, 1998
K964468 — IAMIN WET DRESSING (COPPER-SALINE) · Procyte Corp. · Feb 3, 1997
K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 · Hospital Specialty Co. · Apr 12, 1999

Submission Summary (Full Text)

{0} APR-29-1997 15:25 RMS 913 942 3828 P.02 K970457 # 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. ABD Combine pad Classification Name: Dressing Predicate Device: Hermitage Combine II Dressing Device Description: Comparison: | Material | Dukal | Hermitage Hospital | | --- | --- | --- | | 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 | The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency. | same | Intended Use: The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.