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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K903855
Device Name THE ON-GARD CORD-CADDY
Applicant
On-Gard Systems, Inc.
1900 Grant St.
Suite 710
Denver,  CO  80203
Applicant Contact MARK E WEISS
Correspondent
On-Gard Systems, Inc.
1900 Grant St.
Suite 710
Denver,  CO  80203
Correspondent Contact MARK E WEISS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/21/1990
Decision Date 09/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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