FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EDLICH WOUND MANAGEMENT TRAY
K Number: K905572
·
Decision Mar 12, 1991
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- EDLICH WOUND MANAGEMENT TRAY
- K Number
- K905572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Sorex Medical
- Date Received
- December 12, 1990
- Decision Date
- March 12, 1991
- Product Code
- MCY
- 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCY), ordered by most recent decision date.
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
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CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
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CIRCULON SYSTEM STEP 1
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CIRCULON SYSTEM STEP 2
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Sorex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K923843 | FOGLESS | Mar 25, 1994 | Substantially Equivalent |
| K913036 | PLUME MASTER | Sep 6, 1991 | Substantially Equivalent |
| K911070 | PICC-FIX | Jul 5, 1991 | Substantially Equivalent |
| K911150 | SOREX SAFE-AIR | Jun 28, 1991 | Substantially Equivalent |
| K910315 | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K | Apr 5, 1991 | Unknown |
| K903740 | TRACH-EZE | Dec 6, 1990 | Substantially Equivalent |
| K902410 | MEDICAL PROCEDURE TRAY | Nov 20, 1990 | Unknown |
| K885136 | GRAFT GUARD | Feb 6, 1989 | Substantially Equivalent |