The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Ie Magnetic Extractor.
Device ID | K904668 |
510k Number | K904668 |
Device Name: | IE MAGNETIC EXTRACTOR |
Classification | Endoscopic Magnetic Retriever |
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 | FCC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-15 |
Decision Date | 1991-03-21 |