The following data is part of a premarket notification filed by Contour Medical Technology, Inc. with the FDA for Temperature Probe-tp350.
| Device ID | K952803 |
| 510k Number | K952803 |
| Device Name: | TEMPERATURE PROBE-TP350 |
| Classification | Warmer, Infant Radiant |
| Applicant | CONTOUR MEDICAL TECHNOLOGY, INC. 144 SOUTHWAY BLVD. P.O. BOX 397 Lavergne, TN 37086 |
| Contact | R. Keith Ferrari |
| Correspondent | R. Keith Ferrari CONTOUR MEDICAL TECHNOLOGY, INC. 144 SOUTHWAY BLVD. P.O. BOX 397 Lavergne, TN 37086 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1996-04-04 |