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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator (Laryngo-Tracheal), Topical Anesthesia
510(k) Number K070596
Device Name TOPICAL APPLICATOR
Applicant
Sharn, Inc.
3460 Pointe Creek Ct. # 102
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Sharn, Inc.
3460 Pointe Creek Ct. # 102
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5170
Classification Product Code
CCT  
Date Received03/02/2007
Decision Date 06/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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