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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Patient Position
510(k) Number K932305
Device Name VILA-COOKE(TM) ANESTHESIA PILLOW
Applicant
SHARN, INC.
4801 GEORGE RD., #180
TAMPA,  FL  33634
Applicant Contact JOHN F SPANGLER
Correspondent
SHARN, INC.
4801 GEORGE RD., #180
TAMPA,  FL  33634
Correspondent Contact JOHN F SPANGLER
Regulation Number868.6820
Classification Product Code
CCX  
Date Received05/12/1993
Decision Date 10/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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