510(k) K952226

C-FLEX SEPTAL SPLINTS by Trebay Medical Corp. — Product Code LYA

K952226 is an FDA 510(k) premarket notification submitted by Trebay Medical Corp. for the device "C-FLEX SEPTAL SPLINTS". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Trebay Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
May 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type