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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stroller, Adaptive
510(k) Number K863450
Device Name SULKY SPECIAL
Applicant
Asc Corp.
6518 Denton Dr.
Troy,  MI  48098
Applicant Contact OLAV H BRANNSTROM
Correspondent
Asc Corp.
6518 Denton Dr.
Troy,  MI  48098
Correspondent Contact OLAV H BRANNSTROM
Regulation Number890.3850
Classification Product Code
LBE  
Date Received09/03/1986
Decision Date 10/23/1986
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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