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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K950830
Device Name STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP
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 Number878.4370
Classification Product Code
KKX  
Date Received02/24/1995
Decision Date 05/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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