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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cover, Mattress (Medical Purposes)
510(k) Number K903382
Device Name ALLERGY CONTROL COVERS
Applicant
Allergy Control Products, Inc.
96 Danbury Rd.
Ridgefield,  CT  06877
Applicant Contact ANNETTE MILLER
Correspondent
Allergy Control Products, Inc.
96 Danbury Rd.
Ridgefield,  CT  06877
Correspondent Contact ANNETTE MILLER
Regulation Number880.6190
Classification Product Code
FMW  
Date Received07/27/1990
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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