510(k) K042648

REPROCESSED COLD BIOPSY FORCEPS by Sterilmed, Inc. — Product Code NON

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 20, 2005
Date Received: September 28, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Forceps, Biopsy, Non-Electric, Reprocessed
Device Class: Class I
Regulation Number: 876.1075
Review Panel: GU
Submission Type

same as procode FCL except this product is for the reprocessed device. 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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510(k) K042648

Clearance Details

Device Classification

Other clearances by Sterilmed, Inc.

Other clearances for product code NON