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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 K940409
Device Name M-K HYDROGEL DRESSING
Applicant
Mason-Keller Corp.
119 Harrison Ave.
Roseland,  NJ  07068
Applicant Contact AL CAGGIA
Correspondent
Mason-Keller Corp.
119 Harrison Ave.
Roseland,  NJ  07068
Correspondent Contact AL CAGGIA
Classification Product Code
MGQ  
Date Received01/27/1994
Decision Date 07/11/1994
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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