FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAND NASAL PACKING
K Number: K963856
·
Decision Oct 18, 1996
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
10
Review Days
23
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Basic Information
- Device Name
- RAND NASAL PACKING
- K Number
- K963856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rand Scientific Corp.
- Date Received
- September 25, 1996
- Decision Date
- October 18, 1996
- Product Code
- EMX
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Rand Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961081 | SPIRIT RIDGE SILICONE CARVING BLOCK | May 22, 1996 | Substantially Equivalent |
| K961057 | DURALASTIC SHEETING II | May 16, 1996 | Substantially Equivalent |
| K955777 | PMMA CLASIC | May 16, 1996 | Substantially Equivalent |
| K961124 | THE NAUTILUS | Apr 19, 1996 | Substantially Equivalent |
| K961071 | THE MAGNUM CHIN IMPLANT | Apr 19, 1996 | Substantially Equivalent |
| K961080 | MEDIAL MALAR IMPLANT | Apr 19, 1996 | Substantially Equivalent |
| K961072 | PEC IMPLANT | Apr 19, 1996 | Substantially Equivalent |
| K955366 | TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS | Mar 28, 1996 | Substantially Equivalent |
| K952165 | TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS | Jun 30, 1995 | Substantially Equivalent |