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510(k) K853663

ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR by Travenol Laboratories, S.A. — Product Code LPZ

K853663 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR". The FDA issued a decision of Substantially Equivalent on April 9, 1986. The device falls under product code LPZ (Container, Frozen Donor Tissue Storage), a Class U device. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1986
Date Received
September 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Frozen Donor Tissue Storage
Device Class
Class U
Regulation Number
Review Panel
HO
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

Other clearances for product code LPZ

  • K021702 — CRYOBAG, MODEL CB (August 6, 2002)
  • K915471 — CRYOBAG (March 2, 1994)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K861761 — ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (August 28, 1986)
  • K860511 — AMPU-PAK (August 4, 1986)

FDA data resources