FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALVE, VENT-AWAY TWO-WAY
K Number: K781920
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
33
Review Days
21
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Basic Information
- Device Name
- VALVE, VENT-AWAY TWO-WAY
- K Number
- K781920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
- Date Received
- November 13, 1978
- Decision Date
- December 4, 1978
- Product Code
- CBP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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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 |
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| 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 |