FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
K Number: K083320
·
Decision Mar 6, 2009
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
11
Review Days
114
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Basic Information
- Device Name
- DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
- K Number
- K083320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dukal Corp.
- Date Received
- November 12, 2008
- Decision Date
- March 6, 2009
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Dukal Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE | Mar 26, 2007 | Substantially Equivalent |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | Sep 15, 2006 | Substantially Equivalent |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | May 15, 2002 | Substantially Equivalent |
| K984564 | ETHYL CHLORIDE DISPENSER | Dec 2, 1999 | Substantially Equivalent |
| K970457 | DUKAL ABD COMBINE PAD | May 8, 1997 | Substantially Equivalent |
| K970455 | DUKAL NON ADHERENT DRESSING | May 8, 1997 | Substantially Equivalent |
| K955476 | DUKAL TRANSPARENT WOUND DRESSING | Jan 18, 1996 | Substantially Equivalent for Some Indications |
| K940440 | DUKAL NON-WOVEN GAUZE | Mar 9, 1994 | Substantially Equivalent |
| K936095 | GAUZE SPONGE | Feb 2, 1994 | Substantially Equivalent |
| K931005 | DUKAL SKIN CLOSURE STRIP | Jul 14, 1993 | Substantially Equivalent |