FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CUSTOM PROCEDURE MEDICAL TRAY OR KIT
K Number: K931844
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
13
Review Days
287
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Basic Information
- Device Name
- CUSTOM PROCEDURE MEDICAL TRAY OR KIT
- K Number
- K931844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Custom Medical Products, Ltd.
- Date Received
- April 13, 1993
- Decision Date
- January 25, 1994
- 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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Other Clearances by Custom Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K931417 | STERILE EQUIPMENT COVERS | Jul 6, 1995 | Substantially Equivalent |
| K931456 | SURGICAL DRAPE AND GOWN TRAY | Jul 8, 1994 | Substantially Equivalent |
| K931418 | SURGICAL DRAPE | May 5, 1994 | Substantially Equivalent |
| K931455 | HEAD SHEET | May 5, 1994 | Substantially Equivalent |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | May 5, 1994 | Substantially Equivalent |
| K926519 | SURGICAL GOWN | Aug 12, 1993 | Substantially Equivalent |
| K900847 | ENEMA KIT 'Y' DESIGN | Apr 13, 1990 | Substantially Equivalent |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Apr 13, 1990 | Substantially Equivalent |
| K895084 | APERTURE | Oct 27, 1989 | Substantially Equivalent |
| K893681 | MAMM-AIRE CP | Jul 20, 1989 | Substantially Equivalent |