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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 K953669
Device Name PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING
Applicant
Marketing Perspectives
4405 Nashwood Ln.
Dallas,  TX  75244
Applicant Contact PAT LAMB
Correspondent
Marketing Perspectives
4405 Nashwood Ln.
Dallas,  TX  75244
Correspondent Contact PAT LAMB
Classification Product Code
MGQ  
Date Received08/07/1995
Decision Date 09/22/1995
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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