FDA 510(k)
Substantially Equivalent
🇺🇸 United States
UPDATED STERILE PROCEDURAL KIT
K Number: K863632
·
Decision Sep 29, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
20
Review Days
12
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Basic Information
- Device Name
- UPDATED STERILE PROCEDURAL KIT
- K Number
- K863632
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Biological & Environmental Control Laboratories
- Date Received
- September 17, 1986
- Decision Date
- September 29, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |
| K961327 | BEC NEEDLELESS INJECTION SITE | May 15, 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 |
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | Sep 29, 1986 | Substantially Equivalent |
| K851851 | STERILE ENDOTRACHEAL BRUSHES | Jun 5, 1985 | Substantially Equivalent |