FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILIZATION PROCESS/OUTERWRAP
K Number: K792633
·
Decision Jan 11, 1980
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
4
Applicant Total
72
Review Days
23
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Basic Information
- Device Name
- STERILIZATION PROCESS/OUTERWRAP
- K Number
- K792633
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Procter & Gamble Mfg. Co.
- Date Received
- December 19, 1979
- Decision Date
- January 11, 1980
- Product Code
- KET
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KET | Filters, Cell Collection, Tissue Processing | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KET), ordered by most recent decision date.
DISPOSABLE STERILE SYRINGE FILTERS
FDA 510(k)
FDA Class 1
·Pathology
PCTE MICROPOROUS MEMBRANE FILTER
FDA 510(k)
FDA Class 1
·Pathology
CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON
FDA 510(k)
FDA Class 1
·Pathology
DISPOSABLE SYRINGE FILTERS
FDA 510(k)
FDA Class 1
·Pathology
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 |