FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEOTECH MUCUS TRAP W/CATHETER
K Number: K890425
·
Decision Apr 19, 1989
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
6
Review Days
83
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Basic Information
- Device Name
- NEOTECH MUCUS TRAP W/CATHETER
- K Number
- K890425
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Neotech Products, Inc.
- Date Received
- January 26, 1989
- Decision Date
- April 19, 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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|---|---|---|---|
| K011564 | NEOLEAD | Jan 3, 2002 | Substantially Equivalent |
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| K882203 | NEOTECH UNIVERSAL ADAPTER | Jun 17, 1988 | Substantially Equivalent |
| K880487 | NEOTECH MECONIUM ASPIRATOR (STERILE) | May 6, 1988 | Substantially Equivalent |