THE O-RING SYSTEM - ORS

Implant, Endosseous, Root-form

ATTACHMENTS INTL., INC.

The following data is part of a premarket notification filed by Attachments Intl., Inc. with the FDA for The O-ring System - Ors.

Pre-market Notification Details

Device IDK900099
510k NumberK900099
Device Name:THE O-RING SYSTEM - ORS
ClassificationImplant, Endosseous, Root-form
Applicant ATTACHMENTS INTL., INC. 600 S. AMPHLETT BLVD. San Mateo,  CA  94402
ContactDonna Schmidt
CorrespondentDonna Schmidt
ATTACHMENTS INTL., INC. 600 S. AMPHLETT BLVD. San Mateo,  CA  94402
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-08
Decision Date1991-01-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10841307118503 K900099 000
10841307118497 K900099 000
10841307118190 K900099 000

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