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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chisel (Osteotome)
510(k) Number K952678
Device Name STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT
Applicant
Avail-Southwest Division
13737 Stemmons Fwy.
Dallas,  TX  75234
Applicant Contact ANGEL R DIAZ
Correspondent
Avail-Southwest Division
13737 Stemmons Fwy.
Dallas,  TX  75234
Correspondent Contact ANGEL R DIAZ
Regulation Number878.4820
Classification Product Code
KDG  
Date Received06/12/1995
Decision Date 07/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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