FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APERTURE
K Number: K895084
·
Decision Oct 27, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
13
Review Days
74
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Basic Information
- Device Name
- APERTURE
- K Number
- K895084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Custom Medical Products, Ltd.
- Date Received
- August 14, 1989
- Decision Date
- October 27, 1989
- Product Code
- IZS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZS | Aperture, Radiographic | FDA class 2 | Radiology |
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 |
| 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 |
| K893681 | MAMM-AIRE CP | Jul 20, 1989 | Substantially Equivalent |