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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 K952274
Device Name CHEMOGUARD, P2 HIRISK
Applicant
Biosafety Systems, Inc.
10225 Willow Creek Rd.
San Diego,  CA  92131
Applicant Contact DANIEL J KUN
Correspondent
Biosafety Systems, Inc.
10225 Willow Creek Rd.
San Diego,  CA  92131
Correspondent Contact DANIEL J KUN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/15/1995
Decision Date 08/29/1995
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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