FDA 510(k)
Unknown
🇺🇸 United States
I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI
K Number: K853242
·
Decision Aug 30, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI
- K Number
- K853242
- Clearance Type
- Traditional
- Decision
- Unknown
- Applicant
- U.S. Mfg. & Management, Inc.
- Date Received
- August 1, 1985
- Decision Date
- August 30, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by U.S. Mfg. & Management, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920860 | CONTROLLED PASSIVE MOTION MACHINE | Apr 2, 1992 | Substantially Equivalent |
| K874436 | FLUID SAMPLING PACK | Jan 5, 1988 | Substantially Equivalent |
| K862335 | MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT | Jul 24, 1986 | Substantially Equivalent for Some Indications |
| K842999 | VENI-SHIELD | Sep 24, 1984 | Substantially Equivalent |