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510(k) K903532

UNNA-SLEEVE(TM) by Aci Medical, Inc. — Product Code LLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1990
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legging, Compression, Non-Inflatable
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type

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  • K861645 — MICRO-TRACHEOSTOMY CARE KIT (May 9, 1986)
  • K844309 — IV RATEMETER (January 22, 1985)

Other clearances for product code LLK

  • K873368 — TECNOL COMPRESSION KNEE DRESSING (December 11, 1987)
  • K871889 — COMPRESSION LEGGING DEVICE (August 4, 1987)
  • K834460 — MODEL 1888 ALPHA COS/RESPIRATION CAR (February 13, 1984)