FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMO-TOUCH
K Number: K895195
·
Decision Mar 15, 1990
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
7
Review Days
216
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Basic Information
- Device Name
- CHEMO-TOUCH
- K Number
- K895195
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Resources, Ltd.
- Date Received
- August 11, 1989
- Decision Date
- March 15, 1990
- Product Code
- LZC
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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Other Clearances by Medical Resources, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K931250 | PHYNE-TOUCH PF | Jan 28, 1994 | Substantially Equivalent |
| K914628 | PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF | Nov 7, 1991 | Substantially Equivalent |
| K903559 | HIGH RISK | Dec 21, 1990 | Substantially Equivalent |
| K894212 | PHYNE-TOUCH-STERILE | Aug 29, 1989 | Substantially Equivalent |
| K885096 | PHYNE-VU | Jul 25, 1989 | Substantially Equivalent |
| K890983 | PHYNE-TOUCH (PATIENT EXAMINATION GLOVES) | Apr 28, 1989 | Substantially Equivalent |