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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K933520
Device Name ENDOSCOPIC ANTI-FOG KIT, 100-302-00
Applicant
Avail-Southwest Division
13737 Stemmons Fwy.
Dallas,  TX  75234
Applicant Contact SHARON D CHEATWOOD
Correspondent
Avail-Southwest Division
13737 Stemmons Fwy.
Dallas,  TX  75234
Correspondent Contact SHARON D CHEATWOOD
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/20/1993
Decision Date 08/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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