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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 K870925
Device Name PAD, BED LINEN PROTECTIVE
Applicant
Quality Disposables, Inc.
1720-38 N. Second St.
Philadelphia,  PA  19122
Applicant Contact WILLIAM G BISTLINE
Correspondent
Quality Disposables, Inc.
1720-38 N. Second St.
Philadelphia,  PA  19122
Correspondent Contact WILLIAM G BISTLINE
Regulation Number880.6060
Classification Product Code
KME  
Date Received03/09/1987
Decision Date 03/17/1987
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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