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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Infant Position
510(k) Number K844176
Device Name PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS
Applicant
Premie Comfort Products
3745 Purdue St.
Dallas,  TX  75225
Applicant Contact MARGARET A SINCLAIR
Correspondent
Premie Comfort Products
3745 Purdue St.
Dallas,  TX  75225
Correspondent Contact MARGARET A SINCLAIR
Regulation Number880.5680
Classification Product Code
FRP  
Date Received10/25/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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