FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUKAL SKIN CLOSURE STRIP
K Number: K931005
·
Decision Jul 14, 1993
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
34
Applicant Total
11
Review Days
138
Basic Information
- Device Name
- DUKAL SKIN CLOSURE STRIP
- K Number
- K931005
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DUKAL CORP.
- Date Received
- February 26, 1993
- Decision Date
- July 14, 1993
- Product Code
- FPX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPX), ordered by most recent decision date.
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AWC BUTTERFLY WOUND CLOSURES
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by DUKAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Mar 6, 2009 | Substantially Equivalent |
| 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 |
| K970455 | DUKAL NON ADHERENT DRESSING | May 8, 1997 | Substantially Equivalent |
| K970457 | DUKAL ABD COMBINE PAD | 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 |