FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TS1000 SUCTION TIP
K Number: K883384
·
Decision Nov 2, 1988
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
4
Review Days
85
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Basic Information
- Device Name
- TS1000 SUCTION TIP
- K Number
- K883384
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- M.D. Engineering, Inc.
- Date Received
- August 9, 1988
- Decision Date
- November 2, 1988
- 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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