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510(k) K801783

CATHETER IRRIGATION TRAYS, #3300, 3310 & by The Healthcare Group Laboratories, Inc. — Product Code EYN

K801783 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "CATHETER IRRIGATION TRAYS, #3300, 3310 &". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
July 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Irrigation, Sterile
Device Class
Class II
Regulation Number
876.5980
Review Panel
SU
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)
  • 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)

Other clearances for product code EYN

  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)
  • K900737 — PISTON IRRIGATION TRAY (April 19, 1990)
  • K900736 — BULB IRRIGATION TRAY (April 17, 1990)
  • K792082 — GAVAGE FEEDING SET (November 13, 1979)
  • K791020 — FLUID ADMINISTRATION SET FA-3160 (June 27, 1979)

FDA data resources