The following data is part of a premarket notification filed by Ryder Intl. Corp. with the FDA for Bard Eagle Inflation Device.
| Device ID | K962611 |
| 510k Number | K962611 |
| Device Name: | BARD EAGLE INFLATION DEVICE |
| Classification | Dilator, Urethral |
| Applicant | RYDER INTL. CORP. 100 CURT FRANCIS RD. POST OFFICE BOX 564 Arab, AL 35016 |
| Contact | Dan Clark |
| Correspondent | Dan Clark RYDER INTL. CORP. 100 CURT FRANCIS RD. POST OFFICE BOX 564 Arab, AL 35016 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-03 |
| Decision Date | 1996-10-21 |
| Summary: | summary |