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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
Recalls CDRH Recalls
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