The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Sd Snares.
Device ID | K902735 |
510k Number | K902735 |
Device Name: | SD SNARES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Daniel J Dillon |
Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-21 |
Decision Date | 1990-08-02 |