FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
K Number: K844597
·
Decision Apr 8, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
133
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Basic Information
- Device Name
- MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
- K Number
- K844597
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Xanmed Corp.
- Date Received
- November 26, 1984
- Decision Date
- April 8, 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 |
| K844596 | EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT | Aug 1, 1985 | Unknown |
| 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 |
| K843642 | SUBCLAVIAN LEAD INTRODUCER SYS | Oct 23, 1984 | Substantially Equivalent |
| K843641 | CATHETER INTRODUCER SYSTEM | Oct 23, 1984 | Substantially Equivalent |