FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TU SUCTIONTRAP
K Number: K884944
·
Decision Feb 3, 1989
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
2
Review Days
70
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Basic Information
- Device Name
- TU SUCTIONTRAP
- K Number
- K884944
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Tulan Corp. C/O Richard Hamer Assoc.
- Date Received
- November 25, 1988
- Decision Date
- February 3, 1989
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Tulan Corp. C/O Richard Hamer Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K881805 | TU STOPCOCK | Oct 4, 1988 | Substantially Equivalent |