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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K933636
Device Name DISPOSE-A-SHEET
Applicant
Belmac Healthcare Corp.
One Urban Center, Suite 550
4830 W. Kennedy Blvd.
Tampa,  FL  33609
Applicant Contact DAMON DALE PHELPS
Correspondent
Belmac Healthcare Corp.
One Urban Center, Suite 550
4830 W. Kennedy Blvd.
Tampa,  FL  33609
Correspondent Contact DAMON DALE PHELPS
Regulation Number880.6060
Classification Product Code
KME  
Date Received07/27/1993
Decision Date 01/26/1994
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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