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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscopes, Replacement Batteries, Hand-Held
510(k) Number K971108
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
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 Number886.1570
Classification Product Code
MSG  
Date Received03/26/1997
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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