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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K875011
Device Name DEY-PAK PURIFIED WATER, USP, STERILE
Applicant
Dey Laboratories, Inc.
1011 Detroit Ave.
Concord,  CA  94518
Applicant Contact RAFF, PH.D.
Correspondent
Dey Laboratories, Inc.
1011 Detroit Ave.
Concord,  CA  94518
Correspondent Contact RAFF, PH.D.
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received12/04/1987
Decision Date 01/22/1988
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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