The following data is part of a premarket notification filed by Rex Medical Lp with the FDA for Modification To Short Introducer Sheath.
| Device ID | K042399 |
| 510k Number | K042399 |
| Device Name: | MODIFICATION TO SHORT INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | REX MEDICAL LP 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk REX MEDICAL LP 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-03 |
| Decision Date | 2004-12-17 |
| Summary: | summary |