FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
K Number: K961227
·
Decision Jun 10, 1996
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
7
Review Days
74
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Basic Information
- Device Name
- JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
- K Number
- K961227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J.J. Skinner, Inc.
- Date Received
- March 28, 1996
- Decision Date
- June 10, 1996
- Product Code
- FRG
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by J.J. Skinner, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | May 10, 1996 | Substantially Equivalent |
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | May 3, 1995 | Substantially Equivalent |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | May 11, 1994 | Unknown |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | Apr 11, 1994 | Unknown |
| K903545 | CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS | Nov 13, 1990 | Unknown |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | Aug 31, 1990 | Unknown |