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510(k) K801259

NEEDLE COUNTER-SURE COUNT/100 COUNT by Kleen Test Products — Product Code MMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1980
Date Received
May 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • K853454 — SURE COUNT 5 & 10 SPONGE COUNTER (September 5, 1985)
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  • K852258 — SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER (June 27, 1985)
  • K852257 — SURE-COUNT 15 COUNT NEEDLE COUNTER (June 26, 1985)
  • K844199 — ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET (November 7, 1984)
  • K821396 — OUT-RITE WASTE DISPOSABLE BAG (June 9, 1982)

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