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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K001217
FOIA Releasable 510(k) K001217
Device Name INSIDE VIEW
Applicant
Monadnock Optics, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Applicant Contact LEONARD J BONNELL
Correspondent
Monadnock Optics, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Correspondent Contact LEONARD J BONNELL
Regulation Number876.1500
Classification Product Code
GCM  
Date Received04/17/2000
Decision Date 07/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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