FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K Number: K972700
·
Decision Jul 16, 1998
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
43
Review Days
393
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Basic Information
- Device Name
- EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
- K Number
- K972700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exmoor Plastics , Ltd.
- Date Received
- June 18, 1997
- Decision Date
- July 16, 1998
- Product Code
- KHJ
- 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 |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
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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 |
| 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 |
| K974365 | MILLS INCUS HA SLEEVE | Jan 22, 1998 | Substantially Equivalent |