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510(k) K042367

NYLON THREADED NEEDLE by Aros Surgical Instruments Corp. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2004
Date Received
August 31, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

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