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510(k) K020641

SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 by Worldwide Medical Technologies, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2002
Date Received
February 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Worldwide Medical Technologies, LLC

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  • K022389 — READI-LOAD SYSTEM, MODEL PSS 1820RL (May 6, 2003)
  • K020337 — READI-STRAND; MODEL PSSTRAND (July 29, 2002)
  • K020867 — BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL (May 20, 2002)
  • K991344 — WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS (November 5, 1999)
  • K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (July 31, 1998)
  • K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (June 25, 1998)
  • K981470 — WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (June 19, 1998)

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