FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K Number: K942200
·
Decision Aug 7, 1995
Classifications
1
FEI Numbers
801
Registration Numbers
801
Same Product Code
55
Applicant Total
21
Review Days
459
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Basic Information
- Device Name
- ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
- K Number
- K942200
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thantex Specialties, Inc.
- Date Received
- May 5, 1994
- Decision Date
- August 7, 1995
- Product Code
- LYU
- 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 |
|---|---|---|---|
| LYU | Accessory, Surgical Apparel | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Thantex Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970547 | ISOLYSER SDS SHARPS CONTAINER | Jul 18, 1997 | Substantially Equivalent |
| K961083 | OREX SURGEON'S VEST | Aug 23, 1996 | 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 |