FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
EXMOOR TYMPANOCENTESIS KIT (TK/1)
K Number: K973587
·
Decision Jan 23, 1998
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
4
Applicant Total
43
Review Days
123
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Basic Information
- Device Name
- EXMOOR TYMPANOCENTESIS KIT (TK/1)
- K Number
- K973587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exmoor Plastics , Ltd.
- Date Received
- September 22, 1997
- Decision Date
- January 23, 1998
- Product Code
- JZF
- 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 |
|---|---|---|---|
| JZF | Tube, Ear Suction | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZF), ordered by most recent decision date.
MIDDLE EAR VIEWER AND FLUID COLLECTOR
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SHAH SELF-CLEARING MASTOID SUCTION TUBE
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MICRO FLUID APPLICATOR
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RIGID SUCTION TIPS & RELATED ITEMS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Exmoor Plastics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K093863 | EPIDRUM | May 10, 2010 | Substantially Equivalent |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | Mar 5, 1999 | Substantially Equivalent |
| K980828 | EXMOOR MYRINGOTOMY KIT | Oct 22, 1998 | Substantially Equivalent |
| K981143 | DILKES LASER/SUCTION CANNULAE | Sep 14, 1998 | Substantially Equivalent |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) | Jul 16, 1998 | Substantially Equivalent |
| K981088 | MILLS COLUMELLA PROSTHESIS | Jun 5, 1998 | Substantially Equivalent |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | May 20, 1998 | Substantially Equivalent |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | May 13, 1998 | Substantially Equivalent |
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Jan 27, 1998 | Substantially Equivalent |
| K974365 | MILLS INCUS HA SLEEVE | Jan 22, 1998 | Substantially Equivalent |