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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Powered
510(k) Number K871012
Device Name CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD
Applicant
Cropper Medical, Inc.
330 Hershey St.
(Per Do Memo, Oob)
Ashland,  OR  97520
Applicant Contact DEAN E CROPPER
Correspondent
Cropper Medical, Inc.
330 Hershey St.
(Per Do Memo, Oob)
Ashland,  OR  97520
Correspondent Contact DEAN E CROPPER
Regulation Number890.5380
Classification Product Code
BXB  
Date Received03/13/1987
Decision Date 03/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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