The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origin Secondary Cannula And Trocar.
Device ID | K922460 |
510k Number | K922460 |
Device Name: | ORIGIN SECONDARY CANNULA AND TROCAR |
Classification | Cannula, Surgical, 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 | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-26 |
Decision Date | 1992-09-16 |