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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 K941526
Device Name MODEL 2000 MILD INTERMITTENT SUCTION PUMP
Applicant
Product & Educational Services
313 Sandy Knoll Dr.
Dolestown,  PA  18901
Applicant Contact EDWARD GRIFFITH
Correspondent
Product & Educational Services
313 Sandy Knoll Dr.
Dolestown,  PA  18901
Correspondent Contact EDWARD GRIFFITH
Regulation Number878.4780
Classification Product Code
JCX  
Date Received03/30/1994
Decision Date 05/18/1994
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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