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510(k) K863241

LASER ASSISTED SURGICAL LAPAROSCOPY KITS by Lifestream Int'L, Inc.

K863241 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "LASER ASSISTED SURGICAL LAPAROSCOPY KITS". The FDA issued a decision of Substantially Equivalent on September 12, 1986. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1986
Date Received
August 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Lifestream Int'L, Inc.

  • K964571 — VISION CARDIOPLEGIA DELIVERY SYSTEM (August 8, 1997)
  • K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASER (September 11, 1996)
  • K920178 — CARDIOTOMY RESERVOIR W/20 MICRON FILITER (May 13, 1993)
  • K920618 — AUTOTRANSFUSION SUCTION SET (March 12, 1993)
  • K913181 — AUTOLOGOUS BLOOD PROCESSING SYSTEM (May 20, 1992)
  • K914396 — SURGI LIGHT NON-CONTACT FIBERS (December 23, 1991)
  • K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (October 31, 1991)
  • K911523 — MODIFICATION TO MODEL 90-1460 LASER ADAPTER (April 22, 1991)
  • K910726 — LIGHT-TOUCH AND SURGI LIGHT FIBERS (March 29, 1991)
  • K904491 — TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 (February 1, 1991)

FDA data resources