The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Sheath, Stopcock Accessory.
Device ID | K213207 |
510k Number | K213207 |
Device Name: | Sheath, Stopcock Accessory |
Classification | Hysteroscope (and Accessories) |
Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
Contact | Katharina Campbell |
Correspondent | Jonathan Gilbert Olympus Corporation Of The Americas (OCA) 3500 Corporate Parkway Center Valley, PA 18034 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-29 |
Decision Date | 2021-12-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04042761085915 | K213207 | 000 |