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510(k) K913408

STERILE PLASTIC DRAPE by Acacia Laboratories, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1992
Date Received
July 30, 1991
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 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)
  • 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)
  • K884055 — SURGI-TAG(TM) STERILE LABEL SETS (October 13, 1988)

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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)