Home / 510(k) Clearances / K081864

510(k) K081864

PROLONG by Life-Tech, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2008
Date Received
July 1, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Life-Tech, Inc.

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  • K111355 — ECHOBRIGHT (September 16, 2011)
  • K102813 — EZONO 3000 (June 30, 2011)
  • K102007 — PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, (December 22, 2010)
  • K093662 — ECHOBRIGHT (June 24, 2010)
  • K093485 — VESISCAN (March 16, 2010)
  • K082772 — STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC191 (February 9, 2009)
  • K082056 — ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (November 7, 2008)
  • K082923 — PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, (October 24, 2008)
  • K073187 — PERIPHERAL NERVE BLOCK SUPPORT TRAY (April 22, 2008)

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