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510(k) K942271

LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE by Level 1 Technologies, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1995
Date Received
May 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Level 1 Technologies, Inc.

  • K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM (April 26, 1996)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K911383 — HOTLINE FLUID WARMER (October 17, 1991)
  • K873435 — LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (October 5, 1987)

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