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510(k) K934188

DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART by Deroyal Industries, Inc. — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
August 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stapler, Surgical
Device Class
Class II
Regulation Number
878.4740
Review Panel
SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

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