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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K922910
Device Name MEDICAL BATTERY PACKS
Applicant
Access / God Loves You
P.O. Box 1630
Castle Rock,  CO  80104
Applicant Contact GWEN REED
Correspondent
Access / God Loves You
P.O. Box 1630
Castle Rock,  CO  80104
Correspondent Contact GWEN REED
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received02/19/1992
Decision Date 09/30/1992
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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