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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K924820
Device Name HYPOGRIP(TM)
Applicant
Collett Products
11889 Fiddler Dr.
Boise,  ID  83704
Applicant Contact KENNETH R COLLETT
Correspondent
Collett Products
11889 Fiddler Dr.
Boise,  ID  83704
Correspondent Contact KENNETH R COLLETT
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/28/1992
Decision Date 10/05/1993
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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