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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K875227
Device Name STERILE EMPTY VIALS
Applicant
Allertech, Inc.
7800 S. Elati
Littleton,  CO  80120
Applicant Contact DEBORAH MCQUADE
Correspondent
Allertech, Inc.
7800 S. Elati
Littleton,  CO  80120
Correspondent Contact DEBORAH MCQUADE
Classification Product Code
LDH
Date Received12/22/1987
Decision Date 03/04/1988
Decision Substantially Equivalent (SESE)
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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