FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
JMS HALO APPLICATION TRAY
K Number: K864969
·
Decision Feb 18, 1987
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
9
Review Days
58
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Basic Information
- Device Name
- JMS HALO APPLICATION TRAY
- K Number
- K864969
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Jerome Medical
- Date Received
- December 22, 1986
- Decision Date
- February 18, 1987
- Product Code
- KDD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Jerome Medical
| K Number | Device Name | ||
|---|---|---|---|
| K051918 | RESOLVE OPEN BACK HALO RINGS | Aug 17, 2005 | Substantially Equivalent |
| K930021 | J TONGS | Dec 6, 1995 | Substantially Equivalent |
| K930153 | SYSTEM III HALO RING | Aug 6, 1993 | Substantially Equivalent |
| K882877 | JMS CERVICAL TRACTION DEVICE/HALO DEVICE | Sep 30, 1988 | Substantially Equivalent |
| K870053 | TORQUEDRIVER WRENCH | Mar 11, 1987 | Substantially Equivalent |
| K844490 | TRACTION ACCESSORIES | Feb 21, 1985 | Substantially Equivalent |
| K822780 | CERVICAL BRACE | Oct 6, 1982 | Substantially Equivalent |
| K821582 | WARM'N FORM SPORTS SUPPORTS | Jun 10, 1982 | Substantially Equivalent |