FDA 510(k)
Unknown
🇺🇸 United States
EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
K Number: K844596
·
Decision Aug 1, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
248
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Basic Information
- Device Name
- EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
- K Number
- K844596
- Clearance Type
- Traditional
- Decision
- Unknown
- Applicant
- Xanmed Corp.
- Date Received
- November 26, 1984
- Decision Date
- August 1, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Xanmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K864623 | OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT | Jan 14, 1987 | Substantially Equivalent |
| K844595 | ORTHOPEDIC CUSTOM SURGICAL KIT | Aug 21, 1985 | Substantially Equivalent |
| K844593 | CARDIOVASCULAR CUSTOM SURGICAL KIT | Jun 21, 1985 | Substantially Equivalent |
| K844594 | NEURO CUSTOM SURGICAL KIT | Jun 13, 1985 | Substantially Equivalent |
| K851906 | SURGICAL EYE PACK | May 21, 1985 | Substantially Equivalent |
| K844597 | MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT | Apr 8, 1985 | Substantially Equivalent |
| K843642 | SUBCLAVIAN LEAD INTRODUCER SYS | Oct 23, 1984 | Substantially Equivalent |
| K843641 | CATHETER INTRODUCER SYSTEM | Oct 23, 1984 | Substantially Equivalent |