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510(k) K840742

RIGHT ATRIAL CATHETER by The Healthcare Group Laboratories, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1984
Date Received
February 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by The Healthcare Group Laboratories, Inc.

  • K850035 — EMPTY SOLUTION TRANSFER CONTAINER (June 7, 1985)
  • K842170 — EMPTY SOLUTION TRANSFER CONTAINER (October 19, 1984)
  • K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY (July 23, 1984)
  • K830299 — SOLUTION TRANSFER CONTAINER (February 19, 1983)
  • K822307 — ADHESIVE SPRAY #4050-4060 (September 24, 1982)
  • K822059 — SHOW'RBAG (July 22, 1982)
  • K821480 — RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT (June 17, 1982)
  • K821230 — SOFTIC 49 (May 28, 1982)
  • K821162 — ADHESIVE REMOVER (May 14, 1982)
  • K821172 — EXTERNAL FEMALE URINARY INCONTINENCE (May 10, 1982)

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