FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL DRAPE AND GOWN TRAY
K Number: K931456
·
Decision Jul 8, 1994
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
13
Review Days
472
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Basic Information
- Device Name
- SURGICAL DRAPE AND GOWN TRAY
- K Number
- K931456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Custom Medical Products, Ltd.
- Date Received
- March 23, 1993
- Decision Date
- July 8, 1994
- Product Code
- FYA
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | 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 |
| 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 |
| K931844 | CUSTOM PROCEDURE MEDICAL TRAY OR KIT | Jan 25, 1994 | Unknown |
| 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 |