FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTINENT STOMA SYSTEM & ACCESSORIES
K Number: K844186
·
Decision Jan 15, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
2
Applicant Total
33
Review Days
78
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Basic Information
- Device Name
- CONTINENT STOMA SYSTEM & ACCESSORIES
- K Number
- K844186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
- Date Received
- October 29, 1984
- Decision Date
- January 15, 1985
- Product Code
- KBG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KBG | Trocar, Sinus | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KBG), ordered by most recent decision date.
REPROCESSED TROCARS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
REPROCESSED DISPOSABLE TROCARS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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 |
| 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 |