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510(k) K051019

SAFETY NEEDLE by Sarstedt, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2005
Date Received
April 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sarstedt, Inc.

  • K032150 — SAFETY-MULTIFLY (September 12, 2003)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K024237 — URINE MONOVETTE BORIC ACID (April 14, 2003)
  • K003382 — SARSTEDT NEEDLE PROTECTOR (March 30, 2001)
  • K913622 — HEMOPLUS (January 31, 1992)

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