FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SHOE COVER
K Number: K894383
·
Decision Sep 12, 1989
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
20
Review Days
57
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Basic Information
- Device Name
- DISPOSABLE SHOE COVER
- K Number
- K894383
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Threshold Industries, Inc.
- Date Received
- July 17, 1989
- Decision Date
- September 12, 1989
- 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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FDA Class 1
·General, Plastic Surgery
FAR-EAST SHOE COVERS
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FDA Class 1
·General, Plastic Surgery
CONVERTORS IMPERVIOUS SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SHOE COVER, NON-STERILE
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
Other Clearances by American Threshold Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | Jun 24, 1997 | Substantially Equivalent |
| K953879 | SURGEON'S CAP | Jan 5, 1996 | Substantially Equivalent |
| K953878 | BOUFFANT CAP | Jan 5, 1996 | Substantially Equivalent |
| K952114 | KOOL GARD SINGLES GOWN | Sep 25, 1995 | Substantially Equivalent |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | Sep 25, 1995 | Substantially Equivalent |
| K952116 | COVER GOWN | Sep 5, 1995 | Substantially Equivalent |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | Nov 12, 1993 | Substantially Equivalent |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | Aug 17, 1992 | Substantially Equivalent |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | Jun 22, 1992 | Substantially Equivalent |
| K912110 | DISPOSABLE O.R. TOWEL | Jul 25, 1991 | Substantially Equivalent |