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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K861540
Device Name DISPOSABLE BERMAN AND GUEDEL AIRWAYS
Applicant
Dryden Corp.
10640 E. 59th St.
P.O. Box 36038
Indianapolis,  IN  46236
Applicant Contact PAUL E DRYDEN
Correspondent
Dryden Corp.
10640 E. 59th St.
P.O. Box 36038
Indianapolis,  IN  46236
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5110
Classification Product Code
CAE  
Date Received04/24/1986
Decision Date 05/02/1986
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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