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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K865090
Device Name PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE
Applicant
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Applicant Contact MICHAEL S BARTLETT
Correspondent
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Correspondent Contact MICHAEL S BARTLETT
Date Received12/30/1986
Decision Date 02/19/1987
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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