The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Attic And Mastoid Antrum Middle Ear Implant (emmett Campbell Md Facs Pattern).
| Device ID | K972700 |
| 510k Number | K972700 |
| Device Name: | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | Margaret Blackmore |
| Correspondent | Margaret Blackmore EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-18 |
| Decision Date | 1998-07-16 |
| Summary: | summary |