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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K881264
Device Name PERMA PURE NAFION TUBE DRYER-MODEL ME
Applicant
Perma Pure Products, Inc.
8 Executive Dr.
P.O. Box 2105
Toms River,  NJ  08753
Applicant Contact KERTZMAN
Correspondent
Perma Pure Products, Inc.
8 Executive Dr.
P.O. Box 2105
Toms River,  NJ  08753
Correspondent Contact KERTZMAN
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received03/24/1988
Decision Date 10/25/1988
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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