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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K963558
Device Name CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
Applicant
Contemporary Products, Inc.
530 Riverside Industrial Pwky.
Portland,  ME  04103 -1066
Applicant Contact BARRY A SCHWARTZ
Correspondent
Contemporary Products, Inc.
530 Riverside Industrial Pwky.
Portland,  ME  04103 -1066
Correspondent Contact BARRY A SCHWARTZ
Regulation Number878.4780
Classification Product Code
JCX  
Subsequent Product Code
BTA  
Date Received09/05/1996
Decision Date 12/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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