The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for 'exmoor' Zoellner Sucker Ends.
Device ID | K864937 |
510k Number | K864937 |
Device Name: | 'EXMOOR' ZOELLNER SUCKER ENDS |
Classification | Catheter And Tip, Suction |
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 | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-16 |
Decision Date | 1987-03-30 |