SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM

Mini Endoscope, Gastroenterology-urology

OVAMED CORP.

The following data is part of a premarket notification filed by Ovamed Corp. with the FDA for Saratoga Modular Miniature Endoscope System.

Pre-market Notification Details

Device IDK943593
510k NumberK943593
Device Name:SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
ClassificationMini Endoscope, Gastroenterology-urology
Applicant OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale,  CA  94086
ContactJohn Zink
CorrespondentJohn Zink
OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale,  CA  94086
Product CodeODF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-25
Decision Date1995-03-22

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