FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
GERTIE MARX EPI-SPINAL TRAY
K Number: K943319
·
Decision Jun 30, 1995
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
8
Review Days
354
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Basic Information
- Device Name
- GERTIE MARX EPI-SPINAL TRAY
- K Number
- K943319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Spinal Specialties, Inc.
- Date Received
- July 11, 1994
- Decision Date
- June 30, 1995
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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Other Clearances by Spinal Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960100 | SPINAL SPECIALTIES NERVE BLOCK TRAY | Apr 24, 1996 | Substantially Equivalent |
| K960082 | DISCOGRAPHY KIT | Mar 21, 1996 | Substantially Equivalent |
| K942863 | EPIDURAL NEEDLE | Aug 11, 1995 | Substantially Equivalent |
| K950820 | SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE | Jun 30, 1995 | Substantially Equivalent |
| K944029 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | Jun 30, 1995 | Unknown |
| K941343 | SPINAL ANESTHESIA TRAY | Aug 11, 1994 | Substantially Equivalent |
| K935245 | EPIDURAL ANESTHESIA TRAY | May 2, 1994 | Unknown |