FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONDUCTIVE SHOE COVERS
K Number: K801617
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
72
Review Days
20
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Basic Information
- Device Name
- CONDUCTIVE SHOE COVERS
- K Number
- K801617
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Procter & Gamble Mfg. Co.
- Date Received
- July 15, 1980
- Decision Date
- August 4, 1980
- 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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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 Procter & Gamble Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K873457 | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | Jan 19, 1988 | Substantially Equivalent |
| K873036 | ATTENDS INCONTINENT BRIEF | Jan 19, 1988 | Substantially Equivalent |
| K864673 | UNSCENTED MENSTRUAL PAD | Jan 21, 1987 | Substantially Equivalent |
| K861863 | MODIFIED PROTECTIVE GARMENT | Aug 11, 1986 | Substantially Equivalent |
| K862348 | SINGLE-USE PATIENT UNDERPAD | Jul 2, 1986 | Substantially Equivalent |
| K860598 | MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS | Mar 5, 1986 | Substantially Equivalent |
| K853880 | ATTENDS DISPOS. UNDERPAD | Oct 16, 1985 | Substantially Equivalent |
| K853000 | SCENTED ALWAYS PANTILINERS | Sep 6, 1985 | Substantially Equivalent |
| K852985 | UNSCENTED ALWAYS PANTILINERS | Aug 29, 1985 | Substantially Equivalent |
| K850956 | ALWAYS MAXIPADS - SCENTED | May 14, 1985 | Substantially Equivalent |