The following data is part of a premarket notification filed by Talley Group Ltd. with the FDA for Talley Sd.500 Skin Pressure Evaluator.
| Device ID | K914780 |
| 510k Number | K914780 |
| Device Name: | TALLEY SD.500 SKIN PRESSURE EVALUATOR |
| Classification | Transducer, Miniature Pressure |
| Applicant | TALLEY GROUP LTD. 815 TERMINAL RD. Lansing, MI 48906 |
| Contact | Van Dyke |
| Correspondent | Van Dyke TALLEY GROUP LTD. 815 TERMINAL RD. Lansing, MI 48906 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1991-12-19 |