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510(k) K935199

SURGICAL APPAREL by Associated Hospital Services, Inc. — Product Code KKY

K935199 is an FDA 510(k) premarket notification submitted by Associated Hospital Services, Inc. for the device "SURGICAL APPAREL". The FDA issued a decision of Substantially Equivalent on September 30, 1994. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1994
Date Received
October 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

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  • K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (November 16, 2011)
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FDA data resources