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510(k) K120204

REPROCESSED FEMORAL COMPRESSION DEVICE by Sterilmed, Inc. — Product Code NMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2012
Date Received
January 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular, Reprocessed
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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  • K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)

Other clearances for product code NMF

  • K012574 — REPROCESSED FEMORAL COMPRESSION DEVICE (July 18, 2002)
  • K011832 — VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE (December 21, 2001)