← Product Code EFQ · K970457

# DUKAL ABD COMBINE PAD (K970457)

_Dukal Corp. · EFQ · May 8, 1997 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K970457

## Device Facts

- **Applicant:** Dukal Corp.
- **Product Code:** EFQ
- **Decision Date:** May 8, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **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.

## Predicate Devices

- Hermitage Combine II Dressing

## Submission Summary (Full Text)

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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.

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**Source:** [https://fda.innolitics.com/device/K970457](https://fda.innolitics.com/device/K970457)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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