FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K Number: K862803
·
Decision Nov 14, 1986
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
33
Review Days
115
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Basic Information
- Device Name
- CHESEBROUGH POND'S HYDROCOLLOID DRESSING
- K Number
- K862803
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
- Date Received
- July 22, 1986
- Decision Date
- November 14, 1986
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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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 |
| K851383 | BLISTERFILM TRANSPARENT DRESSING | Jul 5, 1985 | Substantially Equivalent for Some Indications |
| K851382 | CHESEBROUGH-POND'S SEQUENTIAL WOUND 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 |