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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 K853785
Device Name SERIES 2000 MEDS MASK
Applicant
Med Systems
2210 Wilshire Blvd.
Santa Monica,  CA  90403
Applicant Contact DAVIS
Correspondent
Med Systems
2210 Wilshire Blvd.
Santa Monica,  CA  90403
Correspondent Contact DAVIS
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received09/10/1985
Decision Date 12/03/1985
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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