The following data is part of a premarket notification filed by Specialized Health Products International, Inc. with the FDA for Lumiloc (tm) Safety Introducer Needle.
| Device ID | K070449 |
| 510k Number | K070449 |
| Device Name: | LUMILOC (TM) SAFETY INTRODUCER NEEDLE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. 586 WEST 500 SOUTH #200 Salt Lake, UT 84010 |
| Contact | Mark Nelson |
| Correspondent | Mark Nelson SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. 586 WEST 500 SOUTH #200 Salt Lake, UT 84010 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-06-14 |
| Summary: | summary |