The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Endoscope.
Device ID | K921040 |
510k Number | K921040 |
Device Name: | ENDOSCOPE |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ORIGIN MEDSYSTEMS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
Contact | Albert K Chin |
Correspondent | Albert K Chin ORIGIN MEDSYSTEMS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-04 |
Decision Date | 1992-12-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOSCOPE 98127497 not registered Live/Pending |
CHEN, XIAOFENG 2023-08-10 |