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510(k) K842517

UNILET LANCET by Ulster Scientific, Inc. — Product Code FML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Blood Donor
Device Class
Class I
Regulation Number
880.6140
Review Panel
HO
Submission Type

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  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
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Other clearances for product code FML

  • K780181 — GLOVES, FLOOR (February 21, 1978)