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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 K971107
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Applicant Contact KEN HEIMENDINGER
Correspondent
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Correspondent Contact KEN HEIMENDINGER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/26/1997
Decision Date 06/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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