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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name loupe, diagnostic/surgical
510(k) Number K861749
Device Name 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
Applicant
KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Applicant Contact VAN ARSDALE
Correspondent
KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL,  PA  19008
Correspondent Contact VAN ARSDALE
Regulation Number878.4800
Classification Product Code
FSP  
Date Received05/06/1986
Decision Date 05/23/1986
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
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