FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIRAFLO DIALYZER, DISPOSABLE
K Number: K760797
·
Decision Nov 19, 1976
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
55
Review Days
42
Basic Information
- Device Name
- SPIRAFLO DIALYZER, DISPOSABLE
- K Number
- K760797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- BENTLEY LABORATORIES, INC.
- Date Received
- October 8, 1976
- Decision Date
- November 19, 1976
- Product Code
- EJT
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJT), ordered by most recent decision date.
PROMETAL HN86
FDA 510(k)
FDA Class 2
·Dental
BIO 60
FDA 510(k)
FDA Class 2
·Dental
PORTA REFLEX
FDA 510(k)
FDA Class 2
·Dental
PORTA SOLDER 1090 W
FDA 510(k)
FDA Class 2
·Dental
NDX-40 ALLOY
FDA 510(k)
FDA Class 2
·Dental
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by BENTLEY LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K931967 | HE-30 GOLD | Jul 13, 1993 | Substantially Equivalent |
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | Jan 17, 1992 | Substantially Equivalent |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | Nov 15, 1991 | Substantially Equivalent |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | Nov 9, 1990 | Substantially Equivalent |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | Feb 28, 1990 | Substantially Equivalent |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Feb 2, 1988 | Substantially Equivalent |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Jan 5, 1983 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |