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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K921476
Device Name INTERP-1000
Applicant
Qmed, Inc.
100 Metro Park S.
3rd Floor
Laurence Harbor,  NJ  08878
Applicant Contact DENISE A QUEFFELEC
Correspondent
Qmed, Inc.
100 Metro Park S.
3rd Floor
Laurence Harbor,  NJ  08878
Correspondent Contact DENISE A QUEFFELEC
Classification Product Code
LOS
Date Received03/30/1992
Decision Date 10/21/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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