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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetrical, Ac-Powered (And Accessories)
510(k) Number K875123
Device Name ORCEPAD
Applicant
Alton Dean Medical, Inc.
40 S. Redwood Rd.
Suite 102
North Salt Lake City,  UT  84054
Applicant Contact DIXON FORD
Correspondent
Alton Dean Medical, Inc.
40 S. Redwood Rd.
Suite 102
North Salt Lake City,  UT  84054
Correspondent Contact DIXON FORD
Regulation Number884.4900
Classification Product Code
HDD  
Date Received12/15/1987
Decision Date 06/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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