FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MID-STREAM URINE COLLECTION SETS
K Number: K840709
·
Decision Apr 3, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
42
Review Days
46
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Basic Information
- Device Name
- MID-STREAM URINE COLLECTION SETS
- K Number
- K840709
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Concord Laboratories, Inc.
- Date Received
- February 17, 1984
- Decision Date
- April 3, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Other Clearances by Concord Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | May 16, 1989 | Unknown |
| K871825 | MECONIUM SUCTION CATHETER | Jun 29, 1987 | Substantially Equivalent |
| K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 | Jan 6, 1987 | Substantially Equivalent |
| K862039 | CONCORD CARE TRAY | Jul 3, 1986 | Unknown |
| K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH | Jan 10, 1986 | Substantially Equivalent |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Nov 13, 1985 | Substantially Equivalent |
| K851134 | REGIONAL ANESTHESIA TRAYS | Jul 15, 1985 | Unknown |
| K842095 | EPIDURAL TRAYS | Jul 3, 1984 | Substantially Equivalent |
| K841486 | ARTERIAL BLOOD SAMPLING KITS | May 23, 1984 | Substantially Equivalent |
| K840986 | PREFILLED PULSATOR SYRINGE | Apr 5, 1984 | Substantially Equivalent |