The following data is part of a premarket notification filed by Endovations with the FDA for Endo-sponge.
Device ID | K892218 |
510k Number | K892218 |
Device Name: | ENDO-SPONGE |
Classification | Accessories, Cleaning Brushes, For Endoscope |
Applicant | ENDOVATIONS ROSSMOYNE INDUSTRIAL PARK 5020 RITTER ROAD, SUITE 211 Mechanicsburg, PA 17055 |
Contact | Susan P Bjorkman |
Correspondent | Susan P Bjorkman ENDOVATIONS ROSSMOYNE INDUSTRIAL PARK 5020 RITTER ROAD, SUITE 211 Mechanicsburg, PA 17055 |
Product Code | MNL |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-03 |
Decision Date | 1989-05-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10350770928118 | K892218 | 000 |
10680651928112 | K892218 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDO-SPONGE 90861086 not registered Live/Pending |
Aesculap AG 2021-08-02 |
ENDO-SPONGE 86477426 4789447 Live/Registered |
Aesculap AG 2014-12-11 |