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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K993604
Device Name ENDOSCOPIC ANTI FOG DEVICE
Applicant
Mectra Labs, Inc.
Hwy. 231 S.,
2 Quality Way
Bloomfield,  IN  47424
Applicant Contact CHARLES E ALLGOOD
Correspondent
Mectra Labs, Inc.
Hwy. 231 S.,
2 Quality Way
Bloomfield,  IN  47424
Correspondent Contact CHARLES E ALLGOOD
Regulation Number876.1500
Classification Product Code
OCT  
Date Received10/25/1999
Decision Date 03/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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