The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula.
| Device ID | K950700 |
| 510k Number | K950700 |
| Device Name: | BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
| Contact | John A Belucia |
| Correspondent | John A Belucia C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-15 |
| Decision Date | 1995-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405055419 | K950700 | 000 |
| 10653405051411 | K950700 | 000 |
| 10653405051299 | K950700 | 000 |
| 10653405051275 | K950700 | 000 |
| 10653405051268 | K950700 | 000 |
| 10653405051251 | K950700 | 000 |
| 10653405051244 | K950700 | 000 |
| 10653405051237 | K950700 | 000 |