The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, Ir-40, Ir-500, Ir-600,.
| Device ID | K072080 |
| 510k Number | K072080 |
| Device Name: | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Cynthia Engelhardt |
| Correspondent | Cynthia Engelhardt SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2008-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50695085812904 | K072080 | 000 |
| 10695085450009 | K072080 | 000 |
| 20695085460104 | K072080 | 000 |
| 20695085470103 | K072080 | 000 |
| 10695085404002 | K072080 | 000 |
| 50695085460204 | K072080 | 000 |
| 10695085460305 | K072080 | 000 |
| 50695085470203 | K072080 | 000 |
| 30695085470308 | K072080 | 000 |
| 50695085460112 | K072080 | 000 |