FDA 510(k)
Substantially Equivalent for Some Indications
🇺🇸 United States
MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
K Number: K862335
·
Decision Jul 24, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
35
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Basic Information
- Device Name
- MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
- K Number
- K862335
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- U.S. Mfg. & Management, Inc.
- Date Received
- June 19, 1986
- Decision Date
- July 24, 1986
- 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 |
| K853242 | I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI | Aug 30, 1985 | Unknown |
| K842999 | VENI-SHIELD | Sep 24, 1984 | Substantially Equivalent |