FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAY, AUXILLARY BLOCK
K Number: K782069
·
Decision Jan 4, 1979
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
24
Review Days
22
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Basic Information
- Device Name
- TRAY, AUXILLARY BLOCK
- K Number
- K782069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
- Date Received
- December 13, 1978
- Decision Date
- January 4, 1979
- 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 Pharmaseal Div., Baxter Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | Dec 10, 1979 | Substantially Equivalent |
| K792141 | CONTINUOUS FLUSH DEVICE | Dec 5, 1979 | Substantially Equivalent |
| K792019 | PHADECODE XA INHIBITOR ASSAY | Nov 5, 1979 | Substantially Equivalent |
| K791773 | VENTILATOR TUBE WITH FILTER | Oct 22, 1979 | Substantially Equivalent |
| K791156 | AMIPAQUE MYELOGRAM TRAY | Jul 30, 1979 | Substantially Equivalent |
| K790896 | TWO-WAY ANESTHESIA FILTER | Jun 5, 1979 | Substantially Equivalent |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | Apr 24, 1979 | Substantially Equivalent |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | Nov 8, 1978 | Substantially Equivalent |
| K781680 | MONITORING, PRESSURE KIT | Oct 6, 1978 | Substantially Equivalent |
| K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE | Jun 22, 1978 | Substantially Equivalent |