FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZEE TRACTION SPLINT
K Number: K813016
·
Decision Nov 24, 1981
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
37
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- ZEE TRACTION SPLINT
- K Number
- K813016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5850
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Zee Medical Products Co., Inc.
- Date Received
- October 27, 1981
- Decision Date
- November 24, 1981
- Product Code
- HST
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Zee Medical Products Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823501 | ZEE SPHYGMOMANOMETER | Jan 21, 1983 | Substantially Equivalent |
| K813156 | ULTRA-WIDE SAFETY SPECTACLE FRAME | Dec 14, 1981 | Substantially Equivalent |
| K812814 | ZEE SURGICAL INSTRUMENTS | Nov 6, 1981 | Substantially Equivalent |
| K812564 | ZEE LIFE SUPPORT AIR PANTS | Oct 23, 1981 | Substantially Equivalent |
| K812342 | ZEE EXTRICATION DEVICE | Sep 21, 1981 | Substantially Equivalent |
| K812284 | ZEE ELECTRODE-GEL | Sep 8, 1981 | Substantially Equivalent |
| K812022 | ZEE MANUAL RESUSCITATOR | Jul 31, 1981 | Substantially Equivalent |