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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K820454
Device Name THE RED CAP
Applicant
Burron Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Burron Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/18/1982
Decision Date 03/08/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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