FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHOE COVER, NON-STERILE
K Number: K961342
·
Decision Dec 30, 1996
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
8
Review Days
285
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Basic Information
- Device Name
- SHOE COVER, NON-STERILE
- K Number
- K961342
- 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
- Copioumed Intl., Inc.
- Date Received
- March 20, 1996
- Decision Date
- December 30, 1996
- Product Code
- FXP
- 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 |
|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXP), ordered by most recent decision date.
PRIMED SHOE COVERS, PRIMED HEAD COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAR-EAST SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONVERTORS IMPERVIOUS SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED NON-SKID SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Copioumed Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030927 | POWDERED VINYL EXAM GLOVES, WHITE | Apr 17, 2003 | Substantially Equivalent |
| K021961 | POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | Jul 2, 2002 | Substantially Equivalent |
| K021743 | (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW | Jun 10, 2002 | Substantially Equivalent |
| K972624 | POLY (VINYL) EXAM GLOVE, POWDER-FREE | Nov 6, 1997 | Substantially Equivalent |
| K971316 | POLY (VINYL) EXAM GLOVE, POWDERED | Aug 27, 1997 | Substantially Equivalent |
| K965237 | NURSES BOUFFANT CAP | Aug 27, 1997 | Substantially Equivalent |
| K960999 | ISOLATION GOWN | Dec 30, 1996 | Substantially Equivalent |