FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERSORB DRY BURN VEST & PANTS
K Number: K822047
·
Decision Jul 28, 1982
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
33
Review Days
16
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Basic Information
- Device Name
- INTERSORB DRY BURN VEST & PANTS
- K Number
- K822047
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
- Date Received
- July 12, 1982
- Decision Date
- July 28, 1982
- Product Code
- NAB
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | 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 |
| 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 |