FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARACENTESIS TRAYS
K Number: K961863
·
Decision May 28, 1996
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
29
Review Days
14
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Basic Information
- Device Name
- PARACENTESIS TRAYS
- K Number
- K961863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tri-Med, Inc.
- Date Received
- May 14, 1996
- Decision Date
- May 28, 1996
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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| K875224 | HUDSON CRANINAL BURRS | Jan 28, 1988 | Substantially Equivalent |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | Apr 2, 1985 | Substantially Equivalent |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | Apr 2, 1985 | Substantially Equivalent |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | Apr 2, 1985 | Substantially Equivalent |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | Dec 4, 1984 | Substantially Equivalent |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | Nov 13, 1984 | Substantially Equivalent |
| K842399 | 48 HOUR SET CHANGES | Oct 9, 1984 | Substantially Equivalent |