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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K970372
Device Name GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
Applicant
Precision Endoscopy of America, Inc.
10969 Mccormick Rd.
Hunt Valley,  MD  21031
Applicant Contact DANIEL M HONEYWELL
Correspondent
Precision Endoscopy of America, Inc.
10969 Mccormick Rd.
Hunt Valley,  MD  21031
Correspondent Contact DANIEL M HONEYWELL
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FDS  
Date Received01/31/1997
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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