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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, External Body, Negative Pressure, Adult (Cuirass)
510(k) Number K881689
Device Name LINDLEY II RESUSCITATOR
Applicant
Lindley Resuscitator, Inc.
2216 14th St.
Meridian,  MS  39301
Applicant Contact LINDLEY, MD
Correspondent
Lindley Resuscitator, Inc.
2216 14th St.
Meridian,  MS  39301
Correspondent Contact LINDLEY, MD
Regulation Number868.5935
Classification Product Code
BYT  
Date Received04/19/1988
Decision Date 07/08/1988
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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