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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K180366
Device Name EndoTool SubQ
Applicant
Al Pacheco and Associates
2643 Galicia Way
Carlsbad,  CA  92009
Applicant Contact Al Pacheco
Correspondent
Certified Compliance Solutions
11665 Avena Place
Suite 203
San Diego,  CA  92128
Correspondent Contact Al Pacheco
Regulation Number868.1890
Classification Product Code
NDC  
Date Received02/12/2018
Decision Date 09/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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