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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K843502
Device Name 3M LASER IMAGER
Applicant
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact WASHLESKY
Correspondent
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact WASHLESKY
Regulation Number892.2040
Classification Product Code
LMC  
Date Received09/06/1984
Decision Date 11/29/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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