FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
K Number: K954912
·
Decision Dec 6, 1995
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
17
Applicant Total
14
Review Days
44
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Basic Information
- Device Name
- TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
- K Number
- K954912
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4140
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trebay Medical Corp.
- Date Received
- October 23, 1995
- Decision Date
- December 6, 1995
- Product Code
- EQJ
- 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 |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Trebay Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Jan 30, 1996 | Substantially Equivalent |
| K955560 | TREBAY SCOPE IRRIGATED CLEARING SLEEVE | Dec 22, 1995 | Substantially Equivalent |
| K955294 | SOF - ABRASION BUR | Dec 22, 1995 | Substantially Equivalent |
| K955447 | TYMPANOSTOMY TUBE | Dec 21, 1995 | Substantially Equivalent |
| K954795 | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES | Nov 15, 1995 | Substantially Equivalent |
| K954796 | MICRO-INGRESSOR HANDIPIECE | Nov 6, 1995 | Substantially Equivalent |
| K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT | Oct 27, 1995 | Substantially Equivalent |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | Oct 27, 1995 | Substantially Equivalent |
| K954715 | MICRO-PLANER HANDPIECE | Oct 27, 1995 | Substantially Equivalent |
| K952226 | C-FLEX SEPTAL SPLINTS | Aug 11, 1995 | Substantially Equivalent |