FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROLLER KNIFE-TRANSVERSE -SAGITTAL
K Number: K833602
·
Decision Jan 3, 1984
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
6
Applicant Total
24
Review Days
83
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Basic Information
- Device Name
- ROLLER KNIFE-TRANSVERSE -SAGITTAL
- K Number
- K833602
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Microtek Medical, Inc.
- Date Received
- October 12, 1983
- Decision Date
- January 3, 1984
- Product Code
- JYO
- 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 |
|---|---|---|---|
| JYO | Knife, Ear | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
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| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
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| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 9, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |