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510(k) K812639

UNICUFF by Frontier Products — Product Code DXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Vessel Occlusion
Device Class
Class II
Regulation Number
870.2890
Review Panel
CV
Submission Type

Other clearances by Frontier Products

  • K831001 — UNICUFF-BLOOD PRESSURE CUFF (July 28, 1983)
  • K822305 — ORTHO-LEVEL (August 20, 1982)
  • K801099 — UNICUF, BLOOD PRESSURE CUFF (May 30, 1980)

Other clearances for product code DXP

  • K891180 — TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT (June 15, 1989)