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510(k) K043204

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP by Sgarlato Laboratories, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2005
Date Received
November 18, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Sgarlato Laboratories, Inc.

  • K990101 — PAIN CONTROL INFUSION PUMP (March 19, 1999)
  • K982931 — THREADED FIXATION PIN (October 21, 1998)
  • K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE (January 26, 1994)
  • K926237 — O'BRIEN GONIOMETER (August 2, 1993)
  • K922292 — LUNDEEN SUBTALAR PEG IMPLANT (October 23, 1992)
  • K905795 — SGARLATO FLEXIBLE HINGE TOE IMPLANT (May 29, 1991)
  • K884739 — SGARLATO LESSER TOE IMPLANT (May 18, 1989)

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