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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 K943104
Device Name MOLLOY INTUBATING STYLETTE
Applicant
Molloy Corp.
Fourth And Walnut St.S
Lebanon,  PA  17042
Applicant Contact WILLIAM T MERCHANT
Correspondent
Molloy Corp.
Fourth And Walnut St.S
Lebanon,  PA  17042
Correspondent Contact WILLIAM T MERCHANT
Regulation Number868.5790
Classification Product Code
BSR  
Date Received06/29/1994
Decision Date 04/18/1996
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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