The following data is part of a premarket notification filed by General Cardiac Technology, Inc. with the FDA for Heart Hugger Sternum Support Harness.
| Device ID | K882592 |
| 510k Number | K882592 |
| Device Name: | HEART HUGGER STERNUM SUPPORT HARNESS |
| Classification | Binder, Elastic |
| Applicant | GENERAL CARDIAC TECHNOLOGY, INC. 795 CARMEL AVE. SUITE 3 Sunnyvale, CA 94086 |
| Contact | Williams, Jr |
| Correspondent | Williams, Jr GENERAL CARDIAC TECHNOLOGY, INC. 795 CARMEL AVE. SUITE 3 Sunnyvale, CA 94086 |
| Product Code | KMO |
| CFR Regulation Number | 880.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-23 |
| Decision Date | 1988-09-20 |