The following data is part of a premarket notification filed by Pilling Weck Surgical with the FDA for Pilling Weck Surgical Heart Stabilizer Removable Pads.
| Device ID | K992476 |
| 510k Number | K992476 |
| Device Name: | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS |
| Classification | Stabilizer, Heart |
| Applicant | PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Richard G Jones |
| Correspondent | Richard G Jones PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | MWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-26 |
| Decision Date | 2000-09-13 |