FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFECTION CONTROL VALVE
K Number: K841480
·
Decision Apr 25, 1984
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
15
Review Days
16
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Basic Information
- Device Name
- INFECTION CONTROL VALVE
- K Number
- K841480
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Superior Plastic Products Corp.
- Date Received
- April 9, 1984
- Decision Date
- April 25, 1984
- 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 Superior Plastic Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851981 | NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. | Jun 18, 1985 | Substantially Equivalent |
| K843975 | 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE | Nov 20, 1984 | Substantially Equivalent |
| K841945 | ENTERAL FEEDING BOTTLE | Jul 26, 1984 | Substantially Equivalent |
| K841630 | ENTERAL NUTRITION PUMP | Jun 7, 1984 | Substantially Equivalent |
| K840324 | SILICONE SUMP DRAIN 20 & 40 FRENCH | Apr 25, 1984 | Substantially Equivalent |
| K840323 | SILICONE SUCTION & IRRIGATION DRAIN | Apr 25, 1984 | Substantially Equivalent |
| K833687 | DISPOS. ENTERIC FEEDING TUBES W/SAFE-T | Mar 2, 1984 | Substantially Equivalent |
| K833947 | SUPERIOR ENTERNAL FEEDING SYSTEM | Feb 4, 1984 | Substantially Equivalent |
| K820460 | 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION | Mar 8, 1982 | Substantially Equivalent |
| K812312 | STERILE WATER 4OZ. | Nov 13, 1981 | Substantially Equivalent |