The following data is part of a premarket notification filed by Somanetics Corp. with the FDA for Correstore Patch, Models 1.5p2, 2p3, 3p4; Correstore Sizer, Model Crps.
| Device ID | K011487 |
| 510k Number | K011487 |
| Device Name: | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | SOMANETICS CORP. 1653 EAST MAPLE RD. Troy, MI 48083 -4208 |
| Contact | Ronald A Widman |
| Correspondent | Ronald A Widman SOMANETICS CORP. 1653 EAST MAPLE RD. Troy, MI 48083 -4208 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-15 |
| Decision Date | 2001-11-21 |