FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKID RESISTANT, LONG LASTING SHOE COVERS
K Number: K883657
·
Decision Sep 15, 1988
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- SKID RESISTANT, LONG LASTING SHOE COVERS
- K Number
- K883657
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- James River Corp.
- Date Received
- August 26, 1988
- Decision Date
- September 15, 1988
- 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
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NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by James River Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894505 | COTOLIN DRAIN SPONGE AND DRESSING SPONGE | Sep 15, 1989 | Substantially Equivalent |
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | Aug 9, 1989 | Substantially Equivalent for Some Indications |
| K893939 | ISOLATION MASKS | Jul 14, 1989 | Substantially Equivalent |
| K894034 | MODIFIED LABELING OF SURGICAL GLOVES | Jul 14, 1989 | Substantially Equivalent |
| K892580 | CARETOUCH EXAMINATION GLOVES | Jul 14, 1989 | Substantially Equivalent |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | Apr 20, 1989 | Substantially Equivalent |
| K883802 | CARETEX CENTRAL SUPPLY WRAP | Oct 21, 1988 | Substantially Equivalent |
| K884112 | CARETEX OR TOWEL | Oct 13, 1988 | Substantially Equivalent |
| K880431 | CARETEX SURGEON'S HOODS | Feb 24, 1988 | Substantially Equivalent |
| K880481 | CARETEX SURGEON'S CAPS | Feb 24, 1988 | Substantially Equivalent |