The following data is part of a premarket notification filed by Conway Stuart Medical, Inc. with the FDA for Delivery Sheath.
| Device ID | K983415 |
| 510k Number | K983415 |
| Device Name: | DELIVERY SHEATH |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | CONWAY STUART MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
| Contact | Thomas Wehman |
| Correspondent | Thomas Wehman CONWAY STUART MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1998-12-01 |