The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Sucker Ends (zoellner).
Device ID | K942746 |
510k Number | K942746 |
Device Name: | SUCKER ENDS (ZOELLNER) |
Classification | Instrument, Ent Manual Surgical |
Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
Contact | Brian East |
Correspondent | Brian East EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
Product Code | LRC |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-10 |
Decision Date | 1994-08-24 |