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510(k) K974454

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

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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