FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYRINGES
K Number: K760392
·
Decision Nov 2, 1976
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
13
Review Days
89
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Basic Information
- Device Name
- SYRINGES
- K Number
- K760392
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- B. Braun Instruments
- Date Received
- August 5, 1976
- Decision Date
- November 2, 1976
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by B. Braun Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K760384 | STOPPERS | Nov 2, 1976 | Substantially Equivalent |
| K760380 | INTRAVENOUS TRANSFER SET (INTRAFIX) | Nov 2, 1976 | Substantially Equivalent |
| K760386 | CENTRAL VEINOUS PRESSURE SETS | Nov 2, 1976 | Substantially Equivalent |
| K760391 | CATHETER, VEIN (BRAUNULA) | Nov 2, 1976 | Substantially Equivalent |
| K760390 | CATHETER, VEIN (BRAUNULA T) | Nov 2, 1976 | Substantially Equivalent |
| K760387 | CATHETER, CAVA (CAVAFIX) | Nov 2, 1976 | Substantially Equivalent |
| K760385 | EXTENSION SETS | Nov 2, 1976 | Substantially Equivalent |
| K760383 | STOPCOCKS | Nov 2, 1976 | Substantially Equivalent |
| K760381 | BLOOD TRANSFUSION SET (SANGOFIX) | Nov 2, 1976 | Substantially Equivalent |
| K760382 | CONNECTORS | Nov 2, 1976 | Substantially Equivalent |