FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
K Number: K840334
·
Decision Apr 13, 1984
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
11
Review Days
79
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Basic Information
- Device Name
- CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
- K Number
- K840334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Devices, Inc.
- Date Received
- January 25, 1984
- Decision Date
- April 13, 1984
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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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 |
| K843883 | STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN | 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 |
| 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 |