FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
'EXMOOR' SINGLE USE SUCTION TUBE
K Number: K892504
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
43
Review Days
72
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Basic Information
- Device Name
- 'EXMOOR' SINGLE USE SUCTION TUBE
- K Number
- K892504
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Exmoor Plastics , Ltd.
- Date Received
- April 11, 1989
- Decision Date
- June 22, 1989
- Product Code
- LRC
- 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 |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
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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 |
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Jan 23, 1998 | Substantially Equivalent |