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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K941907
Device Name APEX DISPOSABLE INSTRUMENTS
Applicant
Apex Ent., Inc.
P.O. Box 11286
Fairfield,  NJ  07004
Applicant Contact AFTAB AHMED
Correspondent
Apex Ent., Inc.
P.O. Box 11286
Fairfield,  NJ  07004
Correspondent Contact AFTAB AHMED
Regulation Number878.4800
Classification Product Code
MDM  
Date Received04/19/1994
Decision Date 08/26/1994
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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