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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ent Drug
510(k) Number K920842
Device Name AEROSOL DELIVERY SYSTEMS
Applicant
Hospitak, Inc.
1144 Rte. 109
Lindenhurst,  NY  11757
Applicant Contact WILLIAM J LACEY
Correspondent
Hospitak, Inc.
1144 Rte. 109
Lindenhurst,  NY  11757
Correspondent Contact WILLIAM J LACEY
Regulation Number874.5220
Classification Product Code
LRD  
Date Received02/24/1992
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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