FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SETS AND TRAYS
K Number: K844151
·
Decision Nov 7, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
41
Review Days
14
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Basic Information
- Device Name
- SETS AND TRAYS
- K Number
- K844151
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- October 24, 1984
- Decision Date
- November 7, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by I M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | Dec 30, 1992 | Substantially Equivalent |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown |
| K881363 | SYRINGE PREFILLED WITH WATER | Jun 23, 1988 | Substantially Equivalent |
| K880753 | UMBILICAL CORD CLAMP | Apr 27, 1988 | Substantially Equivalent |
| K872741 | NUTRIPUMP | Oct 20, 1987 | Substantially Equivalent |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | May 8, 1987 | Substantially Equivalent |
| K863785 | MAKLER CATHETER | Dec 11, 1986 | Substantially Equivalent |
| K854155 | STERILE SALINE SOLUTION | Dec 10, 1985 | Substantially Equivalent |
| K853287 | HUBOUT | Oct 17, 1985 | Substantially Equivalent |
| K853288 | FEEDING UNITS & TUBES | Oct 4, 1985 | Substantially Equivalent |