The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Gyrus Acmi Uro-ezdilate Ureteral Balloon Dilation Catheter.
Device ID | K132181 |
510k Number | K132181 |
Device Name: | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER |
Classification | Dilator, Catheter, Ureteral |
Applicant | OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
Contact | Neil Kelly |
Correspondent | Neil Kelly OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
Product Code | EZN |
CFR Regulation Number | 876.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-15 |
Decision Date | 2013-10-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925033153 | K132181 | 000 |
00821925033054 | K132181 | 000 |
00821925033061 | K132181 | 000 |
00821925033078 | K132181 | 000 |
00821925033085 | K132181 | 000 |
00821925033092 | K132181 | 000 |
00821925033108 | K132181 | 000 |
00821925033115 | K132181 | 000 |
00821925033122 | K132181 | 000 |
00821925033139 | K132181 | 000 |
00821925033146 | K132181 | 000 |
00821925033047 | K132181 | 000 |