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510(k) K883654

STERI-TAG(TM) STERILE LABEL SETS by Acacia Laboratories, Inc. — Product Code LYV

K883654 is an FDA 510(k) premarket notification submitted by Acacia Laboratories, Inc. for the device "STERI-TAG(TM) STERILE LABEL SETS". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code LYV (Label Or Tag, Sterile), a Class I device regulated under 21 CFR 878.4800. Acacia Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
August 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Label Or Tag, Sterile
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Acacia Laboratories, Inc.

  • K952419 — STERIGAUZE GEL DRESSING (July 26, 1995)
  • K952420 — STERIGAUZE WET DRESSING (July 12, 1995)
  • K951861 — STERICARE WOUND CARE GEL (July 11, 1995)
  • K952414 — PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (June 23, 1995)
  • K951914 — HYDRACARE ABSORBENT WOUND DRESSING (May 15, 1995)
  • K950344 — HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER (March 24, 1995)
  • K913408 — STERILE PLASTIC DRAPE (March 12, 1992)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K892804 — NEWCHILL(TM) CARDIAC INSULATOR (July 14, 1989)

Other clearances for product code LYV

  • K884055 — SURGI-TAG(TM) STERILE LABEL SETS (October 13, 1988)

FDA data resources