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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K880563
Device Name 3M XP515 X-RAY FILM PROCESSOR
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact JOHN A GRAVELLE
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact JOHN A GRAVELLE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received02/10/1988
Decision Date 03/21/1988
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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