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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K950822
Device Name SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL
Applicant
Solopak Laboratories, Inc.
1845 Tonne Rd.
Elk Grove Village,  IL  60007
Applicant Contact RON HASELHORST
Correspondent
Solopak Laboratories, Inc.
1845 Tonne Rd.
Elk Grove Village,  IL  60007
Correspondent Contact RON HASELHORST
Classification Product Code
LDH
Date Received02/22/1995
Decision Date 03/22/1995
Decision Substantially Equivalent (SESE)
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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