FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WOUND CLOSURE/LACERATION TRAY
K Number: K950295
·
Decision Apr 18, 1995
Classifications
1
FEI Numbers
165
Registration Numbers
165
Same Product Code
109
Applicant Total
36
Review Days
84
Basic Information
- Device Name
- WOUND CLOSURE/LACERATION TRAY
- K Number
- K950295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CUSTOMED, INC.
- Date Received
- January 24, 1995
- Decision Date
- April 18, 1995
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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| K961442 | UNIVERSAL DRAINAGE TRAY | May 9, 1996 | Substantially Equivalent |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | Oct 2, 1995 | Substantially Equivalent |
| K942177 | FOLEY CATHETERIZATION TRAY | Sep 8, 1994 | Substantially Equivalent |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | Aug 27, 1993 | Unknown |
| K925017 | IV PREP KIT (NON-STERILE) | Aug 27, 1993 | Substantially Equivalent |