The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Autoclavable Camer Head Model Otv-y0017.
Device ID | K102059 |
510k Number | K102059 |
Device Name: | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWY P.O. BOX 610 Center Valley, PA 18034 -0610 |
Contact | Stacy Abbatiello Kluesner |
Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWY P.O. BOX 610 Center Valley, PA 18034 -0610 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-22 |
Decision Date | 2010-10-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170336669 | K102059 | 000 |
04953170310799 | K102059 | 000 |
04953170310782 | K102059 | 000 |