FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BYRON BIVALVE NASAL SPLINTS
K Number: K863430
·
Decision Sep 17, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
27
Review Days
13
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Basic Information
- Device Name
- BYRON BIVALVE NASAL SPLINTS
- K Number
- K863430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Byron Medical
- Date Received
- September 4, 1986
- Decision Date
- September 17, 1986
- Product Code
- FZE
- 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 |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Byron Medical
| K Number | Device Name | ||
|---|---|---|---|
| K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP | Jun 3, 2004 | Substantially Equivalent |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | Aug 4, 2000 | Substantially Equivalent |
| K981215 | PSI-TEC LIPOSUCTION ASPIRATOR | Jul 1, 1998 | Substantially Equivalent |
| K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES | Jun 30, 1998 | Substantially Equivalent |
| K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION | Jun 16, 1998 | Substantially Equivalent |
| K980392 | PSI-TEC ASPIRATOR | Mar 5, 1998 | Substantially Equivalent |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Feb 10, 1998 | Substantially Equivalent |
| K973133 | BIG BAG 3000 PRESSURE INFUSOR | Sep 12, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K934179 | DISPOSABLE BAG DECANTER | May 23, 1994 | Substantially Equivalent |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | Feb 3, 1994 | Substantially Equivalent |