FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
K Number: K982891
·
Decision Sep 30, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
8
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
- K Number
- K982891
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4420
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- California Medical Laboratories, Inc.
- Date Received
- August 17, 1998
- Decision Date
- September 30, 1998
- Product Code
- DTS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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