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510(k) K041714

E-PAIN CARE by Breg, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2004
Date Received
June 23, 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 Breg, Inc.

  • K183702 — Polar Care Wave (March 1, 2019)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K020988 — PAIN CARE 4200 (April 4, 2002)
  • K013928 — PAIN CARE 3200 (December 3, 2001)
  • K003611 — PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (December 13, 2000)
  • K002073 — PAIN CARE 3000 (September 19, 2000)
  • K002321 — PAIN CARE 2000L (August 14, 2000)
  • K983454 — PAIN CARE 2000 (December 16, 1998)
  • K963596 — POLAR CARE 300 (December 4, 1996)
  • K961855 — POLAR CARE (MODEL 500/50000) (August 9, 1996)

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