The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Endoscopic Overtube.
| Device ID | K942044 |
| 510k Number | K942044 |
| Device Name: | BARD ENDOSCOPIC OVERTUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
| Contact | John A Delucia |
| Correspondent | John A Delucia C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-28 |
| Decision Date | 1994-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405053699 | K942044 | 000 |