The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Disposable Bending Cannula Pr-233q.
Device ID | K011149 |
510k Number | K011149 |
Device Name: | DISPOSABLE BENDING CANNULA PR-233Q |
Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
Contact | Laura Stoms-tyler |
Correspondent | Laura Stoms-tyler THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
Product Code | ODD |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-16 |
Decision Date | 2001-05-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170044240 | K011149 | 000 |