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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K952774
Device Name MULTIDEX GEL
Applicant
Lange Medical Products, Inc.
1676 S. Wolf Rd.
Wheeling,  IL  60090
Applicant Contact LEON FERN
Correspondent
Lange Medical Products, Inc.
1676 S. Wolf Rd.
Wheeling,  IL  60090
Correspondent Contact LEON FERN
Classification Product Code
MGQ  
Date Received06/16/1995
Decision Date 07/24/1995
Decision Substantially Equivalent (SESE)
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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