FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL SPLINT
K Number: K945555
·
Decision Jan 19, 1995
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
24
Review Days
66
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Basic Information
- Device Name
- NASAL SPLINT
- K Number
- K945555
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultracell Medical Technologies, Inc.
- Date Received
- November 14, 1994
- Decision Date
- January 19, 1995
- Product Code
- LYA
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Ultracell Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012196 | ULTRACELL ABSORBENT STICK | Aug 24, 2001 | Substantially Equivalent |
| K972633 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent |
| K972634 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent |
| K973083 | ULTRACELL NEURO SPONGES | Dec 9, 1997 | Substantially Equivalent |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | Nov 24, 1997 | Substantially Equivalent |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Nov 18, 1997 | Substantially Equivalent |
| K972635 | ULTRACELL SUCTION SPONGE | Oct 1, 1997 | Substantially Equivalent |
| K970328 | ULTRACELL NEURO SPONGES | Apr 21, 1997 | Substantially Equivalent |
| K950647 | ULTRACELL NEURO SPONGES | Aug 15, 1995 | Substantially Equivalent |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent |