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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 K920050
Device Name BIOLEX WOUND GEL,
Applicant
Catalina Biomedical Corp.
1850 Evergreen St.
Duarte,  CA  91010
Applicant Contact WALLACE ROGOZINSKI
Correspondent
Catalina Biomedical Corp.
1850 Evergreen St.
Duarte,  CA  91010
Correspondent Contact WALLACE ROGOZINSKI
Classification Product Code
MGQ  
Date Received01/06/1992
Decision Date 04/07/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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