The following data is part of a premarket notification filed by Novasys Medical, Inc. with the FDA for Introducer Sheath.
| Device ID | K001328 |
| 510k Number | K001328 |
| Device Name: | INTRODUCER SHEATH |
| Classification | Obturator, For Endoscope |
| Applicant | NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Contact | Thomas C Wehman |
| Correspondent | Thomas C Wehman NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. Sunnyvale, CA 94086 |
| Product Code | FEC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-07-17 |