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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K881131
Device Name THE LAITINEN STEREOTACTIC SYSTEM
Applicant
Sandstrom Trade & Technology, Inc.
9 Mcnicholl Cir., St.
Catharines
Ontario L2n 7c5,  CA
Applicant Contact MONICA SANDSTROM
Correspondent
Sandstrom Trade & Technology, Inc.
9 Mcnicholl Cir., St.
Catharines
Ontario L2n 7c5,  CA
Correspondent Contact MONICA SANDSTROM
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/16/1988
Decision Date 08/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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