The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Snuggle Warm 4000 Convective Warming System, Model Sw4000.
| Device ID | K040632 |
| 510k Number | K040632 |
| Device Name: | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 |
| Classification | System, Thermal Regulating |
| Applicant | SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Vernon Trimble |
| Correspondent | Vernon Trimble SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-10 |
| Decision Date | 2004-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10695085000075 | K040632 | 000 |