The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Working Element For Probes.
Device ID | K992141 |
510k Number | K992141 |
Device Name: | OLYMPUS WORKING ELEMENT FOR PROBES |
Classification | Resectoscope, Working Element |
Applicant | OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | FDC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-24 |
Decision Date | 1999-09-29 |
Summary: | summary |