HEART HUGGER STERNUM SUPPORT HARNESS
FDA 510(k) clearance K882592 · decided 1988-09-20
Clearance details
- K-number
- K882592
- Device name
- HEART HUGGER STERNUM SUPPORT HARNESS
- Applicant
- General Cardiac Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-23
- Decision date
- 1988-09-20
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KMO
- Device class
- 1
- Regulation number
- 880.5160
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 4 SURE TM RECTAL TUBE (K921852) | Boston Pacific Medical, Inc. | 1993-10-08 |
| COUGH PILLOW (K893809) | Custom Hospitals Products | 1989-08-28 |
| THORACIC SUPPORT SYSTEM (K883214) | Storer Medical Products | 1989-01-17 |
| STERILIZATION PROCESS/T-BINDER (K792629) | Procter & Gamble Mfg. Co. | 1980-01-11 |
Recalls involving this device
No recalls on record reference this clearance.