IMPLANT, SILICONE AND TANTALUM

Implant, Absorbable, (scleral Buckling Methods)

MEDICAL INSTRUMENT RESEARCH ASSOC., INC.

The following data is part of a premarket notification filed by Medical Instrument Research Assoc., Inc. with the FDA for Implant, Silicone And Tantalum.

Pre-market Notification Details

Device IDK760550
510k NumberK760550
Device Name:IMPLANT, SILICONE AND TANTALUM
ClassificationImplant, Absorbable, (scleral Buckling Methods)
Applicant MEDICAL INSTRUMENT RESEARCH ASSOC., INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHQJ  
CFR Regulation Number886.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-08-30
Decision Date1976-10-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20850510007457 K760550 000
20850510007150 K760550 000
20850510007068 K760550 000

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