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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Tracheal Tube
510(k) Number K932081
Device Name LIGHTED INTUBATION SYLET
Applicant
Aaron Medical, Inc.
7100- 30th Ave. N.
St. Petersburg,  FL  33710
Applicant Contact ROBERT SARON
Correspondent
Aaron Medical, Inc.
7100- 30th Ave. N.
St. Petersburg,  FL  33710
Correspondent Contact ROBERT SARON
Regulation Number868.5790
Classification Product Code
BSR  
Date Received04/29/1993
Decision Date 07/27/1993
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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