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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 K850263
Device Name PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
Applicant
Plasmedics, Inc.
638 Main St.
Ashland,  MA  01721
Applicant Contact JEROME L KRASNER
Correspondent
Plasmedics, Inc.
638 Main St.
Ashland,  MA  01721
Correspondent Contact JEROME L KRASNER
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received01/23/1985
Decision Date 03/25/1985
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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