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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851276
Device Name ACTION PAC
Applicant
South Mountain Medical
Twenty-Four Buxton Ave.
Asheville,  NC  28801
Applicant Contact DENNIS E FARRELL
Correspondent
South Mountain Medical
Twenty-Four Buxton Ave.
Asheville,  NC  28801
Correspondent Contact DENNIS E FARRELL
Classification Product Code
LDQ
Date Received04/01/1985
Decision Date 05/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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