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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K033141
Device Name MECHANICAL WHEEHCHAIR
Applicant
Pacific Medical Suppliers, Inc.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact STEPHEN T MLCOCH
Correspondent
Pacific Medical Suppliers, Inc.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact STEPHEN T MLCOCH
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/30/2003
Decision Date 10/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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