510(k) K882592
K882592 is an FDA 510(k) premarket notification submitted by General Cardiac Technology, Inc. for the device "HEART HUGGER STERNUM SUPPORT HARNESS". The FDA issued a decision of Substantially Equivalent on September 20, 1988. The device falls under product code KMO (Binder, Elastic), a Class I device regulated under 21 CFR 880.5160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1988
- Date Received
- June 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Binder, Elastic
- Device Class
- Class I
- Regulation Number
- 880.5160
- Review Panel
- HO
- Submission Type