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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K942033
Device Name R&D BATTERIES, PART NOS. 5243, 5104, AND 5481
Applicant
R & D Batteries, Inc.
2224 E. 117th St.
P.O. Box 5007
Burnsville,  MN  55337
Applicant Contact RANDALL C NODDINGS
Correspondent
R & D Batteries, Inc.
2224 E. 117th St.
P.O. Box 5007
Burnsville,  MN  55337
Correspondent Contact RANDALL C NODDINGS
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/28/1994
Decision Date 06/28/1994
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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