FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN
K Number: K843883
·
Decision Dec 13, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
72
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Basic Information
- Device Name
- STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN
- K Number
- K843883
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Devices, Inc.
- Date Received
- October 2, 1984
- Decision Date
- December 13, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Applied Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843885 | PERCUTANEOUS ASPIRATION BIOPSY TRAY | Dec 19, 1984 | Substantially Equivalent |
| K843884 | GENERAL UTILITY TRAY SYSTEM | Dec 13, 1984 | Substantially Equivalent |
| K840904 | ACCU-CULT FECAL OCCULT BLOOD TEST | Aug 16, 1984 | Substantially Equivalent |
| K842591 | ULTRASOUND PROBE COVERS-STERILE | Jul 23, 1984 | Substantially Equivalent |
| K833720 | TRANSTHORACIC/TRANSABDOMINAL-TRAY | May 30, 1984 | Substantially Equivalent |
| K840334 | CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY | Apr 13, 1984 | Substantially Equivalent |
| K833438 | PREPACELL-STERILE-BONE MARROW ASPIR | Feb 9, 1984 | Substantially Equivalent |
| K833719 | PREPACELL THIN NEEDLE ASPIRATION TRAY | Jan 25, 1984 | Substantially Equivalent |
| K802406 | CYTOTRAN I BONE MARROW ASPIRATION SYSTEM | Jan 15, 1981 | Substantially Equivalent |
| K791660 | PREPACELL-BONE MARROW SAMPLER | Sep 12, 1979 | Substantially Equivalent |