FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHOE COVERS
K Number: K844705
·
Decision Jan 10, 1985
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
14
Review Days
38
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Basic Information
- Device Name
- SHOE COVERS
- K Number
- K844705
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medicon, Inc.
- Date Received
- December 3, 1984
- Decision Date
- January 10, 1985
- 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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FAR-EAST SHOE COVERS
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CONVERTORS IMPERVIOUS SHOE COVERS
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SHOE COVER, NON-STERILE
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FLUID BARRIER BOOT KNEE & ANKLE-HIGH
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FDA Class 1
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NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Medicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962087 | SERVOTRONIC EC100 SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | Jun 22, 1995 | Substantially Equivalent |
| K850855 | TENS GB1001 DEVICE | Jan 9, 1986 | Substantially Equivalent |
| K850852 | INFRARAX DEVICE | Aug 21, 1985 | Substantially Equivalent |
| K844702 | GAUZE ASORBABLE | Apr 1, 1985 | Substantially Equivalent |
| K844573 | ABSORBABLE GAUZE PRODUCTS | Mar 5, 1985 | Substantially Equivalent |
| K844574 | WHEELCHAIRS | Feb 21, 1985 | Substantially Equivalent |
| K844703 | GOWNS, SURGICAL | Jan 10, 1985 | Substantially Equivalent |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Jan 10, 1985 | Substantially Equivalent |
| K840034 | VACUUM STRETCHER IMMOBILIZER | Feb 27, 1984 | Substantially Equivalent |