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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
510(k) Number K061422
Device Name SURGICAL DRAPES
Applicant
Austin Medical, Inc.
3460 Pointe Creek Ct.
# 102
Bonita Springs,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
Austin Medical, Inc.
3460 Pointe Creek Ct.
# 102
Bonita Springs,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/23/2006
Decision Date 09/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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