The following data is part of a premarket notification filed by Techtrade Llc with the FDA for Ready-heat Blanket.
| Device ID | K042145 |
| 510k Number | K042145 |
| Device Name: | READY-HEAT BLANKET |
| Classification | Bedding, Disposable, Medical |
| Applicant | TECHTRADE LLC 11900 GAINSBOROUGH ROAD P.O.BOX 2005 Potomac, MD 20854 -3305 |
| Contact | Arthur M Horowitz |
| Correspondent | Arthur M Horowitz TECHTRADE LLC 11900 GAINSBOROUGH ROAD P.O.BOX 2005 Potomac, MD 20854 -3305 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-09-17 |