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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neurosurgical, Argon
510(k) Number K833497
Device Name COOPER MEDICAL MODEL 770
Applicant
Cooper Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cooper Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LLF  
Date Received10/11/1983
Decision Date 04/17/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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