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510(k) K882592

HEART HUGGER STERNUM SUPPORT HARNESS by General Cardiac Technology, Inc. — Product Code KMO

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

Other clearances for product code KMO

  • K921852 — 4 SURE TM RECTAL TUBE (October 8, 1993)
  • K893809 — COUGH PILLOW (August 28, 1989)
  • K883214 — THORACIC SUPPORT SYSTEM (January 17, 1989)
  • K792629 — STERILIZATION PROCESS/T-BINDER (January 11, 1980)