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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K873591
Device Name A.R.M. (ASPEN RETURN MONITOR)
Applicant
Qmed, Inc.
7651 National Tpke.
Louisville,  KY  40214
Applicant Contact KEN POTTS
Correspondent
Qmed, Inc.
7651 National Tpke.
Louisville,  KY  40214
Correspondent Contact KEN POTTS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/04/1987
Decision Date 09/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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