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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 K945217
Device Name HYDROGEL DRESSING
Applicant
O.R. Resources, Inc.
5212 Bolero Cir.
Delray Beach,  FL  33484
Applicant Contact ALFRED J LINDSEY
Correspondent
O.R. Resources, Inc.
5212 Bolero Cir.
Delray Beach,  FL  33484
Correspondent Contact ALFRED J LINDSEY
Classification Product Code
MGQ  
Date Received10/26/1994
Decision Date 05/12/1995
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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