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510(k) K945732

FOG FREE by Tonn Chemical Co., Inc. — Product Code OCT

K945732 is an FDA 510(k) premarket notification submitted by Tonn Chemical Co., Inc. for the device "FOG FREE". The FDA issued a decision of Substantially Equivalent on January 4, 1995. 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
January 4, 1995
Date Received
November 23, 1994
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