FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTINUOUS EPIDURAL ANESTHES. TRAY
K Number: K840179
·
Decision Feb 24, 1984
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
41
Review Days
38
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Basic Information
- Device Name
- CONTINUOUS EPIDURAL ANESTHES. TRAY
- K Number
- K840179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical Products, Inc.
- Date Received
- January 17, 1984
- Decision Date
- February 24, 1984
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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Other Clearances by Burron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | May 1, 1987 | Substantially Equivalent |
| K862412 | INTESTOPLANT | Nov 13, 1986 | Substantially Equivalent |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Jul 1, 1986 | Unknown |
| K860126 | STIMUPLEX, NERVE STIMULATOR | Feb 28, 1986 | Substantially Equivalent |
| K851293 | IMPLANTOFIX | Jan 9, 1986 | Substantially Equivalent |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | Jul 9, 1984 | Substantially Equivalent |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | May 1, 1984 | Substantially Equivalent |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | May 1, 1984 | Substantially Equivalent |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Apr 30, 1984 | Substantially Equivalent |
| K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | Feb 23, 1984 | Substantially Equivalent |