FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEC NEEDLELESS INJECTION SITE
K Number: K961327
·
Decision May 15, 1996
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
20
Review Days
37
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Basic Information
- Device Name
- BEC NEEDLELESS INJECTION SITE
- K Number
- K961327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biological & Environmental Control Laboratories
- Date Received
- April 8, 1996
- Decision Date
- May 15, 1996
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Biological & Environmental Control Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER | Aug 18, 1997 | Substantially Equivalent |
| K962802 | SAFE MATE I.V. FLUID DELIVERY SETS | Aug 28, 1996 | Substantially Equivalent |
| K962801 | SAFE MATE I.V. EXTENSION SETS | Aug 28, 1996 | Substantially Equivalent |
| K961328 | BEC SHROUDED PLASTIC CANNULA | May 30, 1996 | Substantially Equivalent |
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | Nov 3, 1986 | Substantially Equivalent |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | Oct 16, 1986 | Substantially Equivalent |
| K863636 | UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS | Oct 6, 1986 | Substantially Equivalent |
| K863632 | UPDATED STERILE PROCEDURAL KIT | Sep 29, 1986 | Substantially Equivalent |
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | Sep 29, 1986 | Substantially Equivalent |
| K851851 | STERILE ENDOTRACHEAL BRUSHES | Jun 5, 1985 | Substantially Equivalent |