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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K895220
Device Name THE ON-GARD RECAPPER
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 Number880.5860
Classification Product Code
FMF  
Date Received08/16/1989
Decision Date 11/08/1989
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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