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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glutaraldehyde
510(k) Number K940768
Device Name AD PERFECT
Applicant
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Applicant Contact JACK V SMITH
Correspondent
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Correspondent Contact JACK V SMITH
Regulation Number864.4010
Classification Product Code
IFT  
Date Received02/18/1994
Decision Date 02/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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