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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sheet, Burn
510(k) Number K930759
Device Name CP & S STERILE BURN SHEET
Applicant
Consolidated Products & Services, Inc.
30 Fayette St.
North Quincy,  MA  02171
Applicant Contact ELLEN J O'DONNELL
Correspondent
Consolidated Products & Services, Inc.
30 Fayette St.
North Quincy,  MA  02171
Correspondent Contact ELLEN J O'DONNELL
Regulation Number880.5180
Classification Product Code
FPY  
Date Received02/12/1993
Decision Date 01/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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