FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILIZATION PROCESS/X-RAY DETECT. SPG
K Number: K792630
·
Decision Jan 11, 1980
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
72
Review Days
23
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Basic Information
- Device Name
- STERILIZATION PROCESS/X-RAY DETECT. SPG
- K Number
- K792630
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Procter & Gamble Mfg. Co.
- Date Received
- December 19, 1979
- Decision Date
- January 11, 1980
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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CPR LAP SPONGES
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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TRIANGULAR SPONGES
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 |