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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K902298
Device Name ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
Applicant
Rondex Products, Inc.
P.O. Box # 1829
Rockford,  IL  61110
Applicant Contact GENE R BALDWIN
Correspondent
Rondex Products, Inc.
P.O. Box # 1829
Rockford,  IL  61110
Correspondent Contact GENE R BALDWIN
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received05/22/1990
Decision Date 08/22/1990
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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