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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K891409
Device Name PRECEPT MICRO-GARD LASER MASK
Applicant
Mars White Knight
P.O. Box 6874
Asheville,  NC  28816
Applicant Contact WALT KOGUT
Correspondent
Mars White Knight
P.O. Box 6874
Asheville,  NC  28816
Correspondent Contact WALT KOGUT
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/14/1989
Decision Date 04/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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