DUKAL ABD COMBINE PAD
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 |
Indications for 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
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.
