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510(k) K070930

REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS by Sterilmed, Inc. — Product Code NLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
April 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable, Reprocessed
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
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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Other clearances for product code NLL

  • K070859 — REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS (September 12, 2007)
  • K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (July 11, 2005)