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510(k) K842091

DISPOS. ACU-CUT SOFT TISSUE BIOPSY by The Healthcare Group Laboratories, Inc.

K842091 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "DISPOS. ACU-CUT SOFT TISSUE BIOPSY". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
May 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by The Healthcare Group Laboratories, Inc.

  • K850035 — EMPTY SOLUTION TRANSFER CONTAINER (June 7, 1985)
  • K842170 — EMPTY SOLUTION TRANSFER CONTAINER (October 19, 1984)
  • K840742 — RIGHT ATRIAL CATHETER (July 13, 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)
  • K821161 — EXTERNAL URINARY MALE INCONTINENCE DEV (May 10, 1982)

FDA data resources