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510(k) K090383

SRI LEVEL II SURGICAL GOWN by Sri Surgical — Product Code FYA

K090383 is an FDA 510(k) premarket notification submitted by Sri Surgical for the device "SRI LEVEL II SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on May 29, 2009. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2009
Date Received
February 17, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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FDA data resources