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510(k) K974454

CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 by Tucson Medical Corp. — Product Code OCT

K974454 is an FDA 510(k) premarket notification submitted by Tucson Medical Corp. for the device "CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004". The FDA issued a decision of Substantially Equivalent on December 18, 1997. The device falls under product code OCT (Anti Fog Solution And Accessories, Endoscopy), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1997
Date Received
November 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

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FDA data resources