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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 K882434
Device Name MASK, GAS, ANESTHETIC
Applicant
Eastmed Enterprises, Inc.
5 Pembury Ct.
Marlton,  NJ  08053
Applicant Contact SUPTI PUTATUNDA
Correspondent
Eastmed Enterprises, Inc.
5 Pembury Ct.
Marlton,  NJ  08053
Correspondent Contact SUPTI PUTATUNDA
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received06/14/1988
Decision Date 06/30/1988
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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