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510(k) K852258

SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER by Kleen Test Products

K852258 is an FDA 510(k) premarket notification submitted by Kleen Test Products for the device "SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER". The FDA issued a decision of Substantially Equivalent on June 27, 1985. Kleen Test Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
May 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Kleen Test Products

  • K890039 — KLEEN TEST BASIN SET (October 24, 1989)
  • K890539 — SURE COUNT LIGHT HANDLE COVER (February 27, 1989)
  • K890098 — KLEEN TEST O.R. KIT (January 24, 1989)
  • K853622 — SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 (October 10, 1985)
  • K853454 — SURE COUNT 5 & 10 SPONGE COUNTER (September 5, 1985)
  • K853315 — CAUTERY TIP CLEANING PAD (August 21, 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)
  • K821394 — SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER (June 3, 1982)

FDA data resources