FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHARMA-PLAST SINGLE USE OVERSHOES
K Number: K843475
·
Decision Oct 31, 1984
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
17
Review Days
55
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Basic Information
- Device Name
- PHARMA-PLAST SINGLE USE OVERSHOES
- K Number
- K843475
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Zimmar Consulting , Ltd.
- Date Received
- September 6, 1984
- Decision Date
- October 31, 1984
- 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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NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Zimmar Consulting , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K860322 | CLINISET INFUSION SET | Apr 7, 1986 | Substantially Equivalent |
| K843477 | PHARMA-PLAST RECTAL TIP | Dec 5, 1984 | Substantially Equivalent |
| K843478 | PHARMA-PLAST URIDROP-URIDOME | Dec 5, 1984 | Substantially Equivalent |
| K843468 | PHARMA-PLAST SUCTION SET TYPE YANKAUER | Nov 23, 1984 | Substantially Equivalent |
| K843469 | PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- | Nov 19, 1984 | Substantially Equivalent |
| K843466 | PHARMA-PLAST OXYGEN CATHETER | Nov 19, 1984 | Substantially Equivalent |
| K843467 | PHARMA-PLAST NASAL OXYGEN CANNULA | Nov 19, 1984 | Substantially Equivalent |
| K843470 | PHARMA-PLAST CONNECTING TUBE TYPE SUCT- | Nov 16, 1984 | Substantially Equivalent |
| K843471 | PHARMA-PLAST SYRINGE | Oct 31, 1984 | Substantially Equivalent |
| K843473 | PHARMA-PLAST INSULIN SYRINGE | Oct 31, 1984 | Substantially Equivalent |