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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, Drug
510(k) Number K933774
Device Name IMC SALINE WET DRESSING
Applicant
Inman Medical Corp.
6316 Airport Fwy.
Fort Worth,  TX  76117
Applicant Contact JOHN MAYALL
Correspondent
Inman Medical Corp.
6316 Airport Fwy.
Fort Worth,  TX  76117
Correspondent Contact JOHN MAYALL
Classification Product Code
FRO  
Date Received08/03/1993
Decision Date 11/08/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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