The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Teflon Loop Replacement Prosthesis.
Device ID | K981045 |
510k Number | K981045 |
Device Name: | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS |
Classification | Prosthesis, Partial Ossicular Replacement |
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 | ETB |
CFR Regulation Number | 874.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-20 |
Decision Date | 1998-05-20 |
Summary: | summary |