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510(k) K844199

ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET by Kleen Test Products — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1984
Date Received
October 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Kleen Test Products

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  • 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)
  • K852258 — SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER (June 27, 1985)
  • K852257 — SURE-COUNT 15 COUNT NEEDLE COUNTER (June 26, 1985)
  • K821396 — OUT-RITE WASTE DISPOSABLE BAG (June 9, 1982)
  • K821394 — SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER (June 3, 1982)

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