FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOLYSER SDS SHARPS CONTAINER
K Number: K970547
·
Decision Jul 18, 1997
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
21
Review Days
156
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Basic Information
- Device Name
- ISOLYSER SDS SHARPS CONTAINER
- K Number
- K970547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thantex Specialties, Inc.
- Date Received
- February 12, 1997
- Decision Date
- July 18, 1997
- Product Code
- FMI
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Thantex Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961083 | OREX SURGEON'S VEST | Aug 23, 1996 | Substantially Equivalent |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Aug 7, 1995 | Substantially Equivalent |
| K943626 | ISOLYSER SHARPS MANAGEMENT SYSTEM SMS | Jun 16, 1995 | Substantially Equivalent |
| K945755 | OREX(R) O.R EQUIPMENT DRAPES | May 25, 1995 | Substantially Equivalent |
| K945223 | OREX ISOLATION GOWN | Apr 25, 1995 | Substantially Equivalent |
| K944859 | OREX SURGICAL DRAPES | Feb 28, 1995 | Substantially Equivalent |
| K944827 | OREX SURGEON'S GOWN | Feb 28, 1995 | Substantially Equivalent |
| K943034 | OREX SHOE COVERS | Jan 2, 1995 | Substantially Equivalent |
| K942228 | OREX O.R. TOWEL | Dec 20, 1994 | Substantially Equivalent |
| K940764 | OREX | Dec 19, 1994 | Substantially Equivalent |