Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern)
FDA 510(k) K972700 · Exmoor Plastics , Ltd.
510(k) numberK972700
Submission
- Device name
- Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern)
- Applicant
- Exmoor Plastics , Ltd.
Taunton, GB - Received
- June 18, 1997
- Decision date
- July 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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More from Vascular Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093863 | EpidrumFMF · Traditional | 05/10/2010SE |
| K990366 | Exmoor Suction Clearance KitLRC · Traditional | 03/05/1999SE |
| K980828 | Exmoor Myringotomy KitETD · Traditional | 10/22/1998SE |
| K981143 | Dilkes Laser/Suction CannulaeGEX · Traditional | 09/14/1998SE |
| K981088 | Mills Columella ProsthesisETA · Traditional | 06/05/1998SE |
| K981045 | Exmoor Teflon Loop Replacement ProsthesisETB · Traditional | 05/20/1998SE |
| K974008 | Pfleiderer's Intratympanic CatheterETD · Traditional | 05/13/1998SE |
| K974224 | Endolymphatic Sac to Mastoid T-ShuntESZ · Traditional | 01/27/1998SE |
| K973587 | Exmoor Tympanocentesis Kit (TK/1)JZF · Traditional | 01/23/1998SE |
| K974365 | Mills Incus Ha SleeveETB · Traditional | 01/22/1998SE |
Questions and answers
When was Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern) cleared by the FDA?
Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern) (K972700) received a 510(k) decision of Substantially Equivalent on July 16, 1998, 393 days after the submission was received.
What is the product code of K972700?
The FDA product code is KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), a Class II (moderate risk) device regulated under 21 CFR 874.3620.