FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K Number: K851382
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
33
Review Days
88
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Basic Information
- Device Name
- CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
- K Number
- K851382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
- Date Received
- April 8, 1985
- Decision Date
- July 5, 1985
- Product Code
- NAD
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Chesebrough-Pond'S U.S.A. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K863866 | RESPIRADYNE II(TM) | Jan 28, 1987 | Substantially Equivalent |
| K862803 | CHESEBROUGH POND'S HYDROCOLLOID DRESSING | Nov 14, 1986 | Substantially Equivalent for Some Indications |
| K851383 | BLISTERFILM TRANSPARENT DRESSING | Jul 5, 1985 | Substantially Equivalent for Some Indications |
| K851539 | CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO | Jun 12, 1985 | Substantially Equivalent |
| K843567 | KANGAROO NASOGASTRIC FEEDING TUBE | Feb 14, 1985 | Substantially Equivalent |
| K844186 | CONTINENT STOMA SYSTEM & ACCESSORIES | Jan 15, 1985 | Substantially Equivalent |
| K845010 | CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH | Jan 15, 1985 | Substantially Equivalent |
| K844789 | KANGAROO ACCESS II ENTERAL FEEDING CONTAINER | Jan 2, 1985 | Substantially Equivalent |
| K843128 | FEMALE URINARY INCONTINENCE SYS | Jan 2, 1985 | Substantially Equivalent |
| K843140 | ISOLATE ADHESIVE BANDAGE FOR DRY WOUND | Nov 8, 1984 | Substantially Equivalent |