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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K894786
Device Name BIO-INDUSTRY STIM POCHE(R)
Applicant
The Hader Corp.
Regulatory Consultant
8904 Paddock Ln.
Potomac,  MD  20854
Applicant Contact L KONOPKO
Correspondent
The Hader Corp.
Regulatory Consultant
8904 Paddock Ln.
Potomac,  MD  20854
Correspondent Contact L KONOPKO
Regulation Number868.2775
Classification Product Code
BXN  
Date Received08/01/1989
Decision Date 09/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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